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Thu, 18 Oct 2018 15:06:13 +0000en-UShourly1https://wordpress.org/?v=4.9.1069652041According to the evidence, of course doctors should recommend acupuncture for painhttp://www.abetterwaytohealth.com/according-to-the-evidence-doctors-should-recommend-acupuncture-for-pain/
http://www.abetterwaytohealth.com/according-to-the-evidence-doctors-should-recommend-acupuncture-for-pain/#respondTue, 13 Mar 2018 16:54:32 +0000http://www.abetterwaytohealth.com/?p=1214Last week, the BMJ published an invited head to head debate as to whether doctors should recommend acupuncture for the treatment of pain. Below is my rapid response: What’s most interesting about this discussion of whether or not doctors should recommend acupuncture for pain is a total lack of discussion of the other available treatment options that doctors and patients ...

What’s most interesting about this discussion of whether or not doctors should recommend acupuncture for pain is a total lack of discussion of the other available treatment options that doctors and patients decide amongst and how acupuncture compares in terms of efficacy, effectiveness, safety and cost-effectiveness. Surely this is the only reasonable starting point for any intelligent discussion about how healthcare resources should be utilized to best help this patient population.

If we continue for a moment to look at acupuncture in an artificial vacuum, as Ernst and Hrobjartsson have done here, there are a few things to note. First, the small effect size that they note of acupuncture over sham needling for pain, which given that the review in question discarded the most positive studies constitutes an underestimation,1 both demonstrates specific effects of acupuncture and at the same time, is a completely irrelevant comparison to determine ‘clinical effects.’2 Doctors and patients are not choosing between acupuncture and sham acupuncture needling control; they are choosing between acupuncture, paracetomol, NSAIDs, opioids, surgery, off-label, poorly tolerated, experimental medication in the case of migraines and fibromyalgia, and physiotherapy, all of which are limited in their ability to effectively treat pain whilst introducing considerable and measurable harm. Sham controlled acupuncture trials merely assess two different types of acupuncture needling. Both are often superior to conventional care in terms of pain reduction and improved quality of life, with the highest-quality evidence demonstrating a statistically significant benefit of acupuncture over sham needling, with an effect size greater than that of paracetomol compared to placebo for many types of pain.3

If we look at sham controlled studies of orthopedic surgery, we find not a small difference between surgery and the sham procedure but no difference at all.4 Clearly surgery and acupuncture have similar methodological challenges to being studied using the double-blind RCT study design held as the gold-standard for pharmaceuticals. If lack of practitioner blinding is such a powerful force as the authors suggest, surely this should have a much stronger effect in the case of surgery, which is more invasive and more expensive (factors that we’re told influence acupuncture outcomes), and yet there’s no difference between fake surgery and the real thing when it comes to reducing patients’ pain. It seems odd to argue against something with at least small specific effects and large non-specific effects (in other words, large proven clinical effects in helping patients reduce their pain) rather than something that’s ineffective, invasive and expensive to boot.

It’s also helpful to note that studies of placebo, including Hrobjartsson’s own research, repeatedly and consistently demonstrate that placebos are ineffective and while they can bring short-term benefits for subjective outcome measures such as pain, they don’t work in the long-term at all.56 This is diametrically opposed to what we see in acupuncture research. Acupuncture brings meaningful reduction in pain symptoms that persists at 12 months,7 as Dr Cummings has pointed out. No placebo has been demonstrated to do this so I’m curious if the authors are arguing that acupuncture is a particularly special placebo unlike any other that has ever been studied before. Of course, this would be special pleading, which is an argument firmly rooted in the authors’ own bias rather than faithfully interpreting the evidence in a consistent and objective way in order to best help patients.

If the authors’ reading of the acupuncture mechanism literature stops at the gate control theory as they have stated, I’m confused as to why they feel qualified to comment as subject experts. Specific mechanisms for acupuncture in pain control are numerous and well-documented, involving but not limited to peripheral effects mediated by purinergic signalling and nitric oxide release, spinal reflexes, modulation of endogenous analgesic biochemicals (including endorphins i.e. endogenous morphine, very effective for pain relief!), improved functional connectivity in the brain, modulation of parasympathetic activity and modulation of inflammatory signaling.8

Of course, the ability to articulate how a treatment works has zero relevance for clinical effectiveness, which is what we’re actually discussing. On the other hand, a recent review in this journal that found that paracetamol is even more harmful than generally appreciated, notes that the ‘mechanism of paracetamol’s analgesic action remains largely unknown.’9

This comes after another recent review of paracetamol for spinal pain and osteoarthritis, also published in this journal, that finds that “paracetamol is ineffective in the treatment of low back pain and provides minimal short term benefit for people with osteoarthritis” 10. In short, paracetamol is widely used and prescribed, increases the risk heart attack, stroke, kidney damage, GI bleeding and death, and we don’t know how it works which is moot because it doesn’t work anyways. In that light, doesn’t it seem a bit silly to debate whether or not to recommend a treatment that is repeatedly demonstrated to be efficacious, effective, cost-effective, and safe, where the only question is exactly how much of its sizable clinical effect is down to the specific effects through analgesia induced through mechano-transduction and how much is due to the ambiance of the acupuncture clinic or the caring disposition of the clinician?

Another mainstay of pain treatment in the NHS are NSAIDs. This class of drugs suffers from a paucity of long-term clinical data but are frequently prescribed indefinitely, despite serious risks. A recent review looking at over 400,000 patients, also published in this journal, found that “All NSAIDs, including naproxen, were found to be associated with an increased risk of acute myocardial infarction” (which is fancy medical speak for ‘heart attack’) when taken for any time period, including as little as one week.11 A now out-dated and absurdly conservative estimate shows that the adverse effects of NSAIDs costs the NHS a median estimate of £251 million pounds a year.12 This figure is only based on the cost of treating GI perforation and doesn’t take into account any of the heart attacks and strokes caused by NSAIDs when taken as directed.

Of course, the harms caused by NSAID and paracetamol consumption pale in comparison to those of opioids, which are extremely addictive, frequently debilitating and often lethal (in the UK, deaths related to prescription opioids doubled between 2005 and 200913), which is why until a successful albeit illegal marketing campaign by their manufacturer in the 1990’s, oral opioids were only available as part of end-of life pain management for terminal cancer patients. In this light, it’s interesting to note that the first and only study ever performed on long-term effectiveness of opioids for pain-relief found that those taking opioids were actually in more pain than their non-opioid popping counter-parts.14 Talk about a poor benefit to harm ratio! While NICE guidelines for various pain conditions urge doctors to use these drugs sparingly and as a last resort, recommending against using acupuncture as a treatment for pain directly increases the usage of these drugs, which is clearly in no one’s best interest and makes the recommendations seem disingenuous.

As acupuncture has been repeatedly demonstrated to reduce the consumption of pain medication, including opioids and NSAIDs, surely a discussion of the cost of acupuncture should take this into account, given how much treating the harms of these drugs costs the NHS each year. Indeed, if we look at the cost-benefit ratio of what’s typically offered for pain, it would be more germane to discuss the cost to the NHS and harms to patients of not recommending acupuncture.

Compared to physiotherapy, acupuncture has a much stronger evidence base. As one point of reference, there are over 10,000 trials on Cochrane’s Central Register for acupuncture compared to under 7,000 for physio (ironically, this latter number includes studies of physios doing acupuncture). With this in mind, it’s interesting to note that physios frequently add acupuncture to their practice (the UK’s Acupuncture Association of Chartered Physios boasts over 6,000 members), often after very minimal training, contrary to World Health Organisation safety recommendations. It’s difficult to reconcile why physios would increasingly start using acupuncture if it didn’t work and their own tools that they learned in their training yielded satisfactory results in practice. Are you suggesting that physiotherapy techniques are so ineffective at treating pain that thousands of physios are offering a placebo to their patients instead?

Any discussion about which treatments should be recommended for pain that center on patients’ wellbeing and the allocation of precious healthcare resources should be based on a comparison of the benefits versus the harms of available treatments. This is self-evident. Such an approach, no matter how you slice the evidence-base, leaves acupuncture amongst first-line treatment options for pain, if not a clear winner. If Hrobjartsson and Ernst insist on banging the disproven placebo drum despite repeated demonstration of specific effects, clinical superiority over treatments that themselves are shown to be superior to placebo and despite the scientific community’s clear understanding of specific mechanisms of how acupuncture is able to achieve these results, then the discussion we should be having is not about the ethics of recommending placebos. Rather the discussion would need to be about the ethics of recommending treatments that fail to outperform or in some cases are inferior to a treatment that you claim is s placebo, all while exposing patients to considerable and avoidable harm. That’s the only logically consistent reading of your suggested interpretation. So let’s have a discussion about the ethics of that.

In the interest of patients and the responsible provision of healthcare resources, I sincerely invite the authors to explain: if not acupuncture for pain, then what do they recommend instead and based on what evidence? If they are unable to provide evidence of a more effective treatment, one with stronger evidence of positive effect, one that does not unacceptably harm patients, then perhaps a reconsideration of providing such a respectable platform for such outdated and un-evidenced opinions is appropriate, as it directly puts patients at risk while impeding access to a proven and effective treatment for a poorly treated affliction.

]]>http://www.abetterwaytohealth.com/according-to-the-evidence-doctors-should-recommend-acupuncture-for-pain/feed/01214How to Summarise the Evidence Basehttp://www.abetterwaytohealth.com/how-to-summarise-the-evidence-base/
http://www.abetterwaytohealth.com/how-to-summarise-the-evidence-base/#respondThu, 07 Dec 2017 23:27:39 +0000http://www.abetterwaytohealth.com/?p=1199Earlier this week, a survey of the content of local acupuncturists websites performed by Daniel Ryan, a computer developer, was published in the New Zealand Medical Journal. The article was full of inaccuracies of all shapes and sizes and its successful journey through the peer-review process left many scratching their heads. As one small example, Ryan writes ‘The UK’s National ...

]]>Earlier this week, a survey of the content of local acupuncturists websites performed by Daniel Ryan, a computer developer, was published in the New Zealand Medical Journal. The article was full of inaccuracies of all shapes and sizes and its successful journey through the peer-review process left many scratching their heads.

As one small example, Ryan writes ‘The UK’s National Institute for Health Care Excellence (NICE) no longer recommends using acupuncture for the treatment of any health conditions.” In reality (where the rest of us live), a number of NICE Guidelines do indeed recommend acupuncture (for instance, this one on the management of tension-type headache).

But what’s more worrying is his response when the errors in his publication were pointed out: “Of course they would say there were mistakes. I’ve backed up all my statements . . .” In the above example, he backed up his statement about what all NICE guidelines recommend by citing one single guideline that does not. Even if you don’t have a research, medical or science background (which, incidentally is a pretty good description of Daniel Ryan), obviously the reference wasn’t a validor logical way to support the point. If the New Zealand medical journal wants to allow submissions from lay people off the street, they should consider some sort of mentoring program or additional writing support for non-researchers.

To offer a counter-opinion, the media contacted Kate Roberts of Acupuncture NZ, who holds a Masters and is currently undertaking a PhD. She provided a fully referenced and eloquent counter-point to Ryan’s piece. Poor quality and unsubstantiated claims aside, the article sparked some media attention in New Zealand where the consensus is that the lay PseudoSkeptics came out looking, if it’s possible, even sillier than usual.

Skeptics of a Feather

All that said, what’s more interesting is the response of esteemed Yale neurologist and die-hard Skeptic Steven Novella, MD to the publication and how he weighs in on how to evaluate ‘what the evidence says’ about an intervention, in this case, acupuncture. Amazingly, he seems to defend Ryan’s shoddy attempt at scholarship, demonstrating that he will pretty much support literally anything that agrees with his views on acupuncture.

In his response to the NZ Acupuncture Website-aganza, he accuses Roberts, of ‘mischaracterizing’ the medical literature when she points out that as a whole, the clinical research supports the use of acupuncture for a wide variety of conditions. In contrast to her ‘distortion’ of the literature, he offers some lessons in how to provide a thorough, unbiased and accurate review of the clinical and scientific evidence for acupuncture.

So how do you accurately characterize the scientific literature for an intervention, according to the ‘science-based’ way of doing things? On what basis can Dr Novella demonstrate that Kate Roberts is ‘simply wrong’ about what the medical literature says? Here are the steps.

1) The science-based ‘because I said so’ gambit

Novella starts out teaching us about the acupuncture literature thusly: “A science-based review of acupuncture finds that the claims made for it are highly implausible and there is no single indication for which there is robust evidence of efficacy.” Well, that’s the end of it, eh? I guess we can all go home now, a ‘science-based review of acupuncture’ says that acupuncture definitely doesn’t work.

Curious as to how I had missed such a definitive evidence-based debunking and clicking on the link to the review in question, I’m actually taken to a reprint of an opinion piece written by Steven Novella himself and co-authored by David Colquhoun. Well, that’s funny, I wonder how Dr Novella could confuse an essay he wrote about his own opinion with a piece of independent, high-quality, science-based scholarship? It’s almost as if Dr Novella thinks his op-ed piece is actually a ‘science-based review.’

So let’s take a little segue into the misleading use of the word ‘review’ to make something sound objectively scientific that really isn’t. There are systematic reviews (like the ones we will touch on in a moment) that give very little leeway into what is included in order to arrive at a roughly accurate picture of what the literature shows about a particular clinical area. Then there are non-systematic or ‘narrative reviews,’ and these too should have some modicum of rigour (a textbook might be considered an example) but do allow for cherry-picking.

Novella’s anti-acupuncture Op-Ed piece (appearing alongside a pro-acupuncture opinion piece, which for some reason Novella never mentions) can hardly even be described as a narrative review. It can only be considered a ‘scientific review’ in the same way my nephew’s Christmas list can be considered a ‘scientific review’ on his opinion of what he’d like Santa to bring him. There are no rigorous or objective criteria for what is included and no a priori methods. It’s tantamount to an essay about the author’s feelings on the subject which is fine, but ‘science-based review of acupuncture’ it certainly is not. It’s actually a little bit incredible that Novella still references this essay, where he rests his entire argument on excluding the entirety of the basic science literature into acupuncture’s mechanisms before cherry-picking a couple of studies and then concluding that acupuncture only works a little.

2) Do a ‘random search of Pubmed, use ‘what comes up’ to make generalizations about the literature

Novella’s next step in ‘fairly and rigorously’ evaluating the clinical evidence of acupuncture is to take a ‘random’ stroll down Pubmed where, to everyone’s total amazement, he finds some systematic reviews of acupuncture that are negative. (Gasp!) This is the type of exercise that non-researchers who agree with the point the author is making love but will leave actual researchers cringing. There’s probably a reason why I’ve never seen the methods section of a systematic review start out by saying ‘we decided to pop on over to Pubmed and do a little looky-loo and, by gosh, wouldn’t you know! The first bunch of studies that we happened to look at agreed with our hypothesis. <Mic drop>’

Of course, when I just did a ‘random’ search of Pubmed for systematic reviews of acupuncture, the first reviews were positive. But of course, like Dr Novella’s odd and fairly ironic exercise into lit review, this doesn’t tell us what the literature as a whole shows. And while Dr Novella indicates that he understands that this sort of ‘search’ is complete bologna, it doesn’t stop him with wasting our time with it rather than looking at actual high-quality reviews of the literature as a whole.

So, what evidence does Kate Robert and other researchers use to support the position that acupuncture is backed by clinical evidence?

According to Steven Novella, ‘acupuncture does not work.’ This is scientific fact based on an opinion piece that Novella wrote in 2013, which he amazingly agrees with, and a quick search on Pubmed. Unbiased, rigorous scientific review at its finest.

But Kate Roberts, myself and others (NICE, the NIH, the Royal College of Obstetrics and Gynaecologists, the Cleveland Clinic, Harvard . . .) claim that as a whole, the clinical literature of acupuncture supports its use for a variety of conditions.

Novella muses: “I won’t speculate about the honesty of proponents like Roberts – I don’t know what she really believes, but that does not really matter. It is possible that she simply has a very different idea of what constitutes scientific evidence than I do. I (sic) my experience when a proponent of alternative medicine claims that a treatment is evidence-based or backed by science they mean that there is some study somewhere that was positive.”

So what is Roberts basing her position on? A single study? Well, fortunately, Kate, who holds a Masters of Science and is currently undertaking a PhD, told us what she was basing the interview that Novella is referencing. She based her assertions about what the clinical evidence for acupuncture shows, not on an essay she wrote about her own opinion or a ‘random’ search of Pubmed, like Novella suggests we do, but on the most recent review of all systematic reviews for acupuncture to date.

The review, conducted this past January by Stephen Janz, who holds a Masters in Public Health and Dr John McDonald, PhD, “draws on two prior comprehensive literature reviews, one conducted for the Australian Department of Veterans’ Affairs (DVA) in 2010 and another conducted for the United States Department of Veterans Affairs (USVA) in 2013. The research identified by these reviews was pooled, then a search of further literature from 2013 to 2016 was conducted. Trials were assessed using the National Health and Medical Research Council (NHMRC) levels of evidence, with risk of bias assessed using the Cochrane GRADE system. Results have been tabulated to indicate not just the current state of the evidence, but to indicate how the quality and quantity of evidence has changed from 2005 to 2016. In this review, 122 conditions across 14 broad clinical areas were identified and, of these, only five conditions found ‘no evidence of effect’ for acupuncture. The level of evidence was found by this review to have increased for 24 conditions.” 1

Parting thoughts

Why Dr Novella would omit a recent review of all systematic reviews of acupuncture from a discussion of what the evidence shows, never mind fail to mention that this (amongst other publications) is what Mrs Roberts supported her assertions, is unclear. Perhaps it’s for a similar reason as to why his opinion piece omits all basic science literature on how acupuncture works before pretending to attempt a discussion of the evidence. If we weren’t talking about misinforming the public about a treatment that’s more effective and safer than what’s routinely offered to them, one could even try to find some humour in it.

Novella leaves us with this thought: “We are left with a situation in which acupuncture proponents claim that acupuncture works for a long list of medical indications, and claiming that this is supported by evidence. Meanwhile the actual evidence, fairly and rigorously evaluated, is negative.”

Yes, acupuncture proponents, as well as dozens of independently conducted biomedical guidelines and the top medical institutions in the world, find that the scientific evidence as a whole does indeed support its use for a growing number of conditions, based on the best available published evidence. Meanwhile, ‘the actual evidence’ (by which Novella presumably means his 2013 op-ed piece) ‘fairly and rigorously evaluated’ (by Novella, himself!) ‘is negative.’

]]>http://www.abetterwaytohealth.com/how-to-summarise-the-evidence-base/feed/01199What is the ‘Science-based’ treatment for the prevention of migraine?http://www.abetterwaytohealth.com/what-does-science-based-medicine-recommend-for-migraines/
http://www.abetterwaytohealth.com/what-does-science-based-medicine-recommend-for-migraines/#commentsSun, 01 Oct 2017 22:57:31 +0000http://www.abetterwaytohealth.com/?p=1132Dear Science Based Medicine, Over the years, I’ve followed your work with great interest in an effort to better understand ‘real’ medicine and how it is that treatments can consistently do well in trials and yet, according to ‘Science,’ not really work at all. It’s been very informative and I think I’m getting the hang of it. While I’m pretty ...

Over the years, I’ve followed your work with great interest in an effort to better understand ‘real’ medicine and how it is that treatments can consistently do well in trials and yet, according to ‘Science,’ not really work at all. It’s been very informative and I think I’m getting the hang of it.

While I’m pretty clear on what Science Based Medicine recommends against (pretty much anything that seems silly to the authors), I am more or less in the dark as to what it does recommend. It’s almost as if your site should be called ’Definitely not science-based medicine’ since that’s the preferred topic.

But I’m sure the public would be really interested to know, with real patients in the real world, which treatments does Science Based Medicine actually recommend? Because this is a very large topic, let’s specifically take the example of migraine prevention, partly because Dr Novella is a neurologist so he has clinical expertise here and partly because you specifically recommend against acupuncture, even when it outperforms other treatments. So I think it would help me, not to mention the public and healthcare policy makers, who also recommend acupuncture1, to understand if acupuncture is not a ‘science-based’ treatment for migraine, what in your estimation is?

What is ‘Science Based’ Medicine?

For those who are unfamiliar, a helpful place to begin our discussion is with what it means for medicine to be ‘Science based’ vs ‘Evidence based,’ which is the dominant paradigm in medicine. What follows is a genuine attempt to accurately summarise the SBM position (no intended straw men here) but I welcome clarification and correction, where needed.

He described ‘science’ in terms of five intellectual virtues, not specific to science, but emblematic of science, as follows:

1) Reasonably accounts for all available evidence. “What that means is that you can’t just pick and choose the evidence that you want. You have to account for all the evidence that’s available.”
2) Utilizes valid and internally consistent logic. “If you make an internally inconsistent logical statement, you’re not going to be led to a valid conclusion.”
3) Intellectually thorough, rigorous and methodical
4) Reasonably fair and unbiased in judgments
5) Adheres to standards of ethics and professionalism

When describing Evidence Based Medicine, in contrast, Dr Novella explained that EBM ‘assumes that products and practices that work and are safe are better than those that do not work or are unsafe.’ If you’re a patient, doctor or healthcare policy maker, you might be thinking this sounds like a pretty good way to go. But unfortunately while this approach may lead to safe and effective treatment options, it wouldn’t be appropriately labeled ‘science-based’ and would demonstrate a sad lack of critical thinking.

The main problem with the EBM approach, Dr Novella points out, is that it ignores ‘prior probability’ and does not adequately consider the ‘big picture’ of the entire literature. In other words, in randomized clinical trials, patients might have excellent results from a treatment like, say, acupuncture compared to usual care, pharmaceuticals, even sham needling. But if you don’t stop to consider how silly acupuncture seems in theory to a conventionally trained doctor, then you might incorrectly recommend it when you could recommend treatments that don’t work as well but seem more rational because they involve chemicals.

So EBM’s main weakness, according to SBM, is that it doesn’t go far enough, which is to say that it currently focuses too much on clinical evidence (how treatments effect patients), comparative effectiveness (which treatments work better than others) and safety and not enough on logic and prior probability (which treatments in theory should work). “Good science considers both.”

“Reasonably accounts for all available evidence”

The first virtue of Science Based Medicine, and the one that according to Science Based Medicine most distinguishes it from plain old Evidence Based Medicine, which is too focused on unscientific things like clinical evidence for what works and minimizes harm to patients, is that it “reasonably accounts for all available evidence. What that means is that you can’t just pick and choose the evidence that you want. You have to account for all the evidence that’s available.”

This approach sounds reasonable, if not a bit less relevant to patients than EBM.

So what I don’t understand, and hopefully you can provide some insight, is in the 2013 opinion piece, ‘Acupuncture is a Theatrical Placebo’, Colqhoun and Novella write that the number one thing NOT relevant to the discussion as to whether acupuncture is effective is the basic science research into acupuncture’s biochemical and neurological mechanisms: “We see no point in discussing surrogate outcomes, such as functional magnetic resonance imaging studies or endorphin release studies, until such time as it has been shown that patients get a useful degree of relief.” In other words, they only want to look at clinical evidence of their choosing, and completely ignore the entirety of the basic science literature for acupuncture. This approach is precisely the thing they accuse EBM of doing and what they claim makes them superior and more ‘Science’-based than their medical colleagues. When it’s pointed out that the clinical evidence for acupuncture is moderate to strong for dozens of clinical conditions2, they explain the results through placebo, non-specific effects, and regression to the mean (aspects of all treatments), having deemed the mechanism literature irrelevant.

What the basic science literature tells us is that acupuncture needling functions at least in part as a mechanical stimulus that results in a number of local and central effects (‘local’ being where you’re inserting the needle and ‘central’ being in the brain and spinal cord, both clinically helpful!). It causes fibroblasts (cells responsible for communication, remodeling and healing of the fascia) to stretch and degranulate, releasing a number of signaling molecules that act on local afferent nerves, which are more dense at acupuncture points.3 It also initiates purinergic signaling through the release of ATP and adenosine, which provides local anti-inflammatory effects as well as binding to local afferents that carry central signals. Interestingly, this release was found at an acupuncture point but not at the control point, lending support for specific effects.4

Downstream of the purines, other biochemicals involved in disease resolution, such as nitric oxide,5 BDNF6 and CGRP7 are released and regulated. Furthermore, unlike traditional ‘placebos’ that are known (sometimes but not always) to result in endorphin release, acupuncture, but not sham acupuncture needling, has been shown to increase receptivity to endorphins in the brain.8

So how is leaving out this literature consistent with considering all available evidence? Isn’t this the complete diametric opposite of your position to reasonably account for all available evidence and not rely solely on clinical evidence? A recent review of all available systematic review evidence (which Harriet Hall recently referred to as ‘cherry-picking,’ suggesting she may want a refresher on what the term means) found moderate or high-quality evidence that acupuncture provides a ‘useful degree of relief’ for 46 different conditions.9 On what grounds can you declare that this is entirely due to placebo if you consider the basic science literature on the physiological and biochemical effects of needling irrelevant? Is this internally logical, consistent, unbiased and ethical?

Equally, we could look at the other available treatments for migraine prophylaxis, at least some of which Dr Novella and others at SBM presumably recommend. Looking at the most common treatments for migraine prophylaxis, what does the basic science research say about beta-blockers for migraine? Is migraine caused by an over-activation of the sympathetic nervous system, such that chemically castrating this system is a logical recourse? Or anti-epileptics such as topiramate and valproate? Can you point me to the basic science research that demonstrates how these work for migraine? Do you test your migraine patients for serotonin deficiency before putting them on SSRI’s and pizotifen? Do drugs have biological plausibility for any condition no matter how they work because they’re drugs? If so, is that really scientific?

Or might this concept of ‘biological plausibility,’ the key feature that separates Science Based Medicine from the majority of mainstream medicine that just ‘doesn’t get it,’ actually be a subjective judgment based on what you choose to read?

‘Utilizes valid and internally consistent logic’

‘If you make an internally inconsistent logical statement, you’re not going to be led to a valid conclusion.’

The second virtue of Science, and Science Based Medicine by extension, is that it utilizes valid and internally consistent logic. I agree that logical consistency is a very helpful concept when studying medicine. Of course, as pointed out previously, one might ask how classifying all basic science research into acupuncture as irrelevant to a discussion of its mode of action can be considered internally consistent and logical, but I’m sure a valid explanation is forthcoming.

But let’s take another simple example of what is usually meant by ‘logical consistency.’ Let’s say you have a treatment that we’ll call Treatment A and you test it against another treatment, which we’ll call Treatment B. We might test these two against each other and discover that patients who were given Treatment A were significantly more likely to have a 50% reduction in their migraines than those given Treatment B. We could summarise these results by saying that Treatment A is more effective than Treatment B.

Further, if Treatment B is a sugar pill controlling for the effects of placebo, we might say ‘Treatment A is more effective than Placebo.’

Now, let’s say you have a further experiment, where one group gets Treatment A and another group gets a 3rd treatment, Treatment C (we might even have Waitlist Control D, to control for regression to the mean). And in this experiment, more patients who received Treatment C, had a 50% reduction in migraine than those receiving Treatment A.

So using a very simple model of internally consistent logic (applying what is known in geeky math-speak as Transitive Law), we would say that, by definition, Treatment C works better than placebo. If A is better than placebo and C is better than A, C is also better than placebo. If pharmaceuticals are better than placebo and acupuncture is better than pharmaceuticals, acupuncture is better than placebo. This is how logic works.

‘But, Mel,’ you say, ‘complex physical interventions have larger placebo effects than pills. In theory, acupuncture could work better at preventing migraine than sugar pill and the real drug and still be a theatrical placebo. Sure, in adequately powered trials, acupuncture does significantly outperform sham needling, but only by a little. This difference could be completely down to lack of blinding of the practitioner.’

Sure, that’s a possibility. But is that the most likely explanation based on the evidence? Are acupuncture’s results for reducing migraines consistent with other placebos? What the heck do we know about placebos anyway?

There seems to be a lot of misunderstanding around what placebos are and how to accurately tease out their effects from other specific and non-specific phenomena10 but there are two things that we do know: “In reality, placebos don’t do much; their effects tend to be small in magnitude and short in duration.” 11

Small in magnitude and short in duration. In other words, placebos have small effect sizes and only work in the short-term. A 2010 Cochrane systematic review of placebo treatments for all conditions supports this first point. They found that compared to no-treatment, placebos were associated with small effect sizes.12 In contrast, for migraine prevention, acupuncture is associated with moderate to large effects. Whether the outcome measure is headache frequency, responder rate, migraine attacks or migraine days, unlike a placebo, acupuncture demonstrates large effect sizes compared to no treatment.13

The placebo review also found that compared to no-treatment, sham-acupuncture needling has large effect sizes, whereas other sham treatments like TENS, had little to no effect. This data supports the contention of experts that sham-needling is not a placebo or inert sham control14 and that the difference between acupuncture and sham-needling is not the measure of its true effect size.15

We also know from research into placebos that they only work in the short-term; this finding is equally true for migraine reduction. A recent systematic review and meta-analysis looked at the effects of placebo for migraines in 78 studies that included 4,579 episodic migraine sufferers randomized to placebo. Before treatment, these patients averaged 5.3 headaches/month. After taking the placebo, they had a significant reduction in headache frequency one month into the study that persisted at 12 weeks. However, by weeks 16, 20, and 24, the patients were having just as many headaches as before.16

In contrast, acupuncture has significant effects compared with no treatment, sham needling and drug-intervention at 3-4 month follow-up.17 Likewise, a recent review found that the majority of acupuncture’s clinical effects are maintained one year after treatment.18

So looking at this again, placebos and shams have small effects over no treatment and only work in the short term. Acupuncture has large effects over no treatment and its clinical effects persist in the long-term.

Applying that internally consistent logic thingy again, wouldn’t you have to conclude that acupuncture is not a placebo? Especially if you decide to include all the evidence and look at all that ‘irrelevant’ basic science research?

You seem to argue that, despite the basic science research demonstrating mechanisms through mechanotransduction and other neurological and biochemical effects of acupuncture needling, that acupuncture’s superiority to drugs is still fully placebo and other non-specific effects. It’s just an uncharacteristically large and long-acting, perhaps paradoxical and unique, placebo, which sounds a little bit like special pleading (a practice that uninterested and unbiased parties don’t tend to engage in).

No matter how you slice it, meta-analyses demonstrate that whatever acupuncturists are offering, it’s working as well as, if not better and more safely than, the alternatives when it comes to migraine prevention. If it’s not down to empathy, then what is it? How is it that acupuncture, which you argue is a placebo, outperforms conventional treatment? Which itself outperforms placebo? Which brings us to the virtue of ‘ethics’ in making recommendations. But first, let’s look at Virtue Number 3.

‘Intellectually thorough, rigorous and methodical’

Yep, this also sounds good. If it were available in a 12 oz can, I’d happily chug the whole thing.

So let’s be intellectually thorough, rigorous and methodical about reasonable treatment options for migraine prophylaxis. From my understanding, your main objection is that acupuncture doesn’t work because there’s no such thing as Qi or channels. Hopefully, that’s a fair categorization. If it’s not, no doubt you can clarify your position.

Assuming that’s a fair categorization, then let me clarify something first. If what you’re saying is that there isn’t an invisible ‘life force energy’ that flows through some as yet undiscovered physical structure referred to as a ‘channel’, I’m actually with you on that. That description simply isn’t a good translation or characterization of the Chinese medical model and certainly not been what’s discussed at any research conferences that I’ve attended.

However, if we’re going to take a stab at being ‘methodical,’ answer me this: can you explain the logic involved in the position that despite copious clinical research to the contrary, acupuncture doesn’t work because there’s no such thing as an invisible life force energy? Isn’t it possible that there’s no invisible, hitherto undiscovered life force energy AND AT THE SAME TIME acupuncture is effective at reducing migraines, as the best evidence supports?

Apparently, claiming that if an argument for some conclusion is fallacious, then the conclusion is false, is known as the ‘fallacy fallacy.‘ I love the way you skeptics name these things! Now, just because your position contains false logic, doesn’t in itself mean that acupuncture is effective for migraine prevention (that would actually be the ‘fallacy fallacy fallacy’, I kid you not). No, for that we have clinical research.

However you slice it, arguing that something doesn’t work despite ample evidence to the contrary because you perceive the model used to explain how it works as inaccurate isn’t exactly intellectually thorough, rigorous or methodical (if not downright logically fallacious!)

This faulty reasoning reminds me of a video I recently watched about a new light that runs on a kinetic motor so it’s powered simply using a weight and some gravity. (How frickin’ cool is that!) This one item is revolutionizing lives and allowing people in remote villages to have reliable access to light without the use of expensive and harmful kerosene.

In some regions of Kenya where the light is being distributed, the villagers, not understanding the mechanics of how the light works off the grid, are said to believe that it works using ‘supernatural power.’

If this situation were analogous to your current arguments about acupuncture, you’d be saying that the light doesn’t work because it can’t work since there’s no such thing as supernatural forces, even though everyone can clearly see that it does work (but perhaps then you’d be arguing that they just think they see light, that it’s another example of post hoc ergo propter hoc. I mean, just because they turned on the light and things got brighter, doesn’t mean that turning on the light caused illumination), not to mention that we can measure the photons it emits and that other explanations, consistent with dominant models explain how it works, at least to the extent that most drugs are understood. Such an argument would be clearly nonsensical. Whether or not the light works has nothing to do with whether the villagers explain that it works via these supernatural powers or not.

And there’s also the possibility, since we’re being thorough and rigorous in our approach and examining the phenomenon from all sides, that the villagers aren’t actually simpletons who lack the intellectual rigor to understand how the light works. It’s possible that the villagers speak a rare and poorly understood dialect of their language and that the people translating those explanations into English didn’t understand what the villagers were actually saying and mis-represented their position, making them look ‘pre-scientific’ and ‘superstitious’. It’s possible that a more accurate and nuanced, albeit less popular, translation of their worldview demonstrates a perspective that’s remarkably prescient and perhaps even includes models that have better explanatory power than the ones most widely used in conventional medicine. <Cue eye-rolls>

Let me anticipate your next objection: that if acupuncture doesn’t work by accessing ‘life force energy’ in ‘channels’ than those who are describing it as such are misleading the public and committing fraud. Or in your words: “it is misleading to say that such mechanisms (purinergic signaling, nitric oxide release, phosphorylation of collagen, etc) could explain “acupuncture.” Acupuncture is the needling of acupuncture points to affect the flow and balance of chi. Using needles to mechanically produce a temporary local counter-irritation effect is not acupuncture.”

Well, not to be whatever, but who died and made ‘Science Based Medicine’ the Supreme Arbiter of acupuncture definitions? This is a classic argumentum ad dicitonarium fallacy and very unscientific. Wouldn’t you be less at risk of being mistaken on this issue if you asked, for example, some of your tens of thousands of colleagues who are dually trained MDs and acupuncturists? Sure, it’s possible that all of them suffered brain aneurysms after medical school (oy, the stress!) and lost their ability to think critically. But you might just find that you have a lot more common ground than you’d expect and it’s also possible, if not probable, that those who have trained in acupuncture are in a better position to discuss definitions than those simply looking at ways to discredit it. It is simply incorrect to say that there is one, singular definition of acupuncture that relies on scientifically unvalidated concepts. The only reason for making such a claim is to disprove it, which not only reflects a strong bias, but one that prevents joining understanding with empiricism. Which leads us to the next ‘virtue’ in your shiny, ‘science-based’ halo.

‘Reasonably fair and unbiased in judgments’

Science, and the medicine it’s based on, should be reasonably fair and unbiased in judgments.

This point is another that sounds wonderful in theory but may be a bit hard to demonstrate its validity in practice. From where I’m sitting, science can’t make judgments. Only people can do that. And furthermore, science demonstrates that the study of science is biased and that the best we can do is be intellectually honest and aware of our biases in order to minimize them and do the best by our patients.19

Let’s say for example, that your intention is to improve public health by informing patients about their treatment options and drawing attention to the problems with certain treatments, using science and research. If that’s the goal, then can you explain any reason why your top priority wouldn’t be drawing attention to and recommending against the treatments that have the poorest benefit to harm ratios first? Why would you start with treatments that consistently demonstrate a superior benefit to harm profile, which you hypothesize is due to placebo and that basic science research demonstrates is due to mechano-transduction, rather than treatments that usually don’t work and have really nasty side-effects?

Is there a possibility that by choosing to focus on and criticise treatments with demonstrated effectiveness that seem illogical and silly to you (but not to the majority of your colleagues), that you might possibly be encouraging the use of more dangerous, and less effective treatments? And that this might be arising from the mistaken (and unscientific) belief that you can be unbiased? That you’re communicating a scientific perspective rather than spreading the good Gospel of Science?

Or we can put it another way. Your bias is that we shouldn’t recommend treatments based solely on demonstrated effectiveness and efficacy as Evidence Based Medicine suggests; treatments should also have known mechanisms and a reasonable level of prior plausibility, a measure that in itself is highly subjective. That’s your prerogative but isn’t that something that patients should get to decide for themselves?

From familiarizing myself with your work, the biggest assumption that I’ve seen you repeat without testing is this idea that there even are ‘treatments that work’ and ‘treatments that don’t’ in any absolute sense. If that’s a fair categorization, that you believe that a treatment can ‘work’ in an absolute binary sense, rather than a comparative ‘at a population level, the group that had this treatment had significantly better results than the other group but not so good as this 3rd group and none of this tells us how my patient, Jane Smith, is going to do on this treatment’, are you able to provide scientific support for this viewpoint? On the basis of what evidence are you supporting this theory of absolute, rather than relative, effectiveness?

Let’s look at an example.

A recent systematic review looked at responder rates amongst various drugs commonly used for migraine prevention, where a responder was defined as someone who had at least a 50% reduction in their migraines. Even amongst the drugs that had significantly more responders than placebo pill, none of them achieved a response in greater than half of those who took them. In other words, if you say that a drug ‘works’ in some sort of theoretical absolute Platonic sense when it significantly outperforms placebo, by that definition these drugs ‘work.’ But the best research also shows that when given to a group of migraine patients, they usually don’t work. So even migraine drugs that ‘work’ usually don’t work. How does that work? How does that work with the whole ‘internally consistent logic’ thing?

Now again, I honestly don’t know what the ‘Science-based’ recommendation is for migraine prophylaxis and I’m eager to hear what it is and what evidence this is based on. But systematic reviews and medical guidelines tend to conclude something like this: “Selection of prophylactic medication should be tailored according to patient preferences, characteristics and side effect profiles.” 20 If that does indeed echo your position, then on what basis can you recommend these treatments as science-based? Unless you’re now broadening your definition of science-based medicine to include the old n=1 ‘none of these drugs work particularly well and all of these have pretty nasty side-effects so let’s just try something and see how we get on?’

On the same token, the most recent Cochrane systematic review demonstrates that acupuncture has greater than 50% responder rate, or in other words, acupuncture usually works for migraine prevention (by ‘works’, I mean both that in systematic reviews of randomised controlled trials, patients with migraines who have acupuncture are more likely to be a responder than those who don’t in a way statistically unlikely due to chance and comparatively, patients who receive acupuncture have better results than those who receive drugs). I know that your position is that this is due to placebo rather than mechanano-transduction, purinergic signaling, and CGRP regulation, but are you sure that recommending a trial and error approach of treatments that usually don’t work and have unpleasant and often dangerous side-effects over a treatment that usually works and is very safe represents a ‘reasonably fair and unbiased judgment’ and puts patient safety and results over theory and your own personal beliefs?

‘Adheres to standards of ethics and professionalism’

Science Based Medicine consistently takes the position that offering placebos to patients, even without deception, is unethical. Personally, I believe that medical ethics (and the law) indicate that patients have a right to informed consent, including knowing when a treatment with a worse benefit to harm profile is out performed by a treatment that you call a placebo.

But let’s leave the ethics of prescribing placebos aside for a moment and let me ask you a different question. What are the ethics of prescribing a treatment that is inferior to placebo? If acupuncture is just a placebo and outperforms conventional pharmaceuticals, which have their own significant placebo built right in, then doesn’t internally consistent logic tell us quite clearly that these treatments are not only not helping but causing overt harm to patients?

Aside from the harm of not being as effective as acupuncture, these treatments used for migraine prophylaxis come with other harms that are relevant to a discussion of what Science Based Medicine recommends for these patients.

A recent review of prophylactic drugs for migraine found the following: “Drowsiness was the most common side effect, increased among patients taking gabapentin, pizotifen, topiramate, TCA and valproate. Tricyclic antidepressants also caused dry mouth and weight gain. Beta-blockers were associated with feeling depressed, dizzy and insomnia. Topiramate increased rates of nausea and paresthesia. Pizotifen had marked increased rates of weight gain with participants averaging 4.3 kg.”21 Of course, medical treatment isn’t all about the harm it can cause as all treatment carries some risk. However, the balance between benefits and harms of preventative migraine drugs is a poor one, leading to frequent discontinuation.

While NSAIDs were not included in the above Jackson review, the JAMA summary of migraine prevention does mention them based on a clinical guideline from the American Academy of Neurology22. While it’s nice to include NSAIDs, presumably to increase the number of options as there’s no evidence that they work, they’re not without their risks. They can cause everything from peptic ulcer and GI bleeding, to hepatitis, cirrhosis, renal stenosis, congestive heart failure, and asthma.23 According to one review in the United States, regular NSAID use causes 200,000-400,000 hospitalizations from upper GI disease a year with an annual cost of 0.8-1.6 billion dollars.24 These staggering figures don’t even include the incidence and cost of heart attacks caused by NSAIDs. A recent review found that taking any dose of NSAIDs for even short periods was associated with an increased risk of heart attack.25 Of course all of this makes sense, since the prostaglandins that NSAIDs lower actually do kind of important things in the body, like protect the gastric mucosa, regulate renal blood flow, support healthy lung function and regulate vasoconstriction and platelet aggregation. So based on how they work, we wouldn’t really expect them to be safe.

In contrast to acupuncture which is considered safe in pregnancy,26 none of the pharmaceutical preventatives are considered to be safe, as they can lead to congenital malformations, miscarriage and seizures in newborns.

To be sure, just because there aren’t any overwhelmingly effective or safe pharmaceutical treatments for migraine prevention doesn’t necessarily mean that acupuncture works; the evidence for that comes from systematic reviews of clinical trials. But if you’re choosing amongst treatments that don’t ‘work’ anyways, shouldn’t you at least be recommending the safest ones first? Especially when they work better than the more dangerous ones? Or is that somehow inconsistent with the ‘Science-based’ medical model?

Wrap up

“In theory, theory and practice are the same. In practice, they’re not.” Attributed to Albert Einstein, Yogi Berra, and others.

Looking at the practice of acupuncture as a whole, I will concede that there’s great heterogeneity in treatment styles and it would be interesting, if not useful, to study which techniques, theories and aspects of treatment work best, particularly in a way that is faithful to actual practice. I will also concede that while many Chinese medical theories are clinically useful and are consistent with modern science, some descriptions and understandings may be past their sell-by date or are based on a misunderstanding of the original theory. Just like with conventional medicine or any category of thought, we find the good, the bad, and the ugly; logic nor science supports equating any category with the worst that one can find within it (known as the ‘fallacy of composition‘).

That said, when it comes to migraine prevention, acupuncture clearly works, both in the ‘absolute’ sense (those who have acupuncture are more likely to have a significant reduction in migraine than those who don’t, unlike those who take pharmaceutical treatments for migraine) and in the more relevant, relative sense (acupuncture is more effective than pharmaceuticals, usual care, and sham needling for migraine prevention).27

It also doesn’t share the defining clinical features of placebos, in that unlike placebos, which only have small effects compared to no treatment and only work in the short-term, acupuncture has large effects compared to no treatment and has meaningful long-term clinical effects. It doesn’t walk or talk like a placebo; thus, it ain’t no placebo.

In light of the above, it may be worthwhile to review what makes science ‘scientific’? What are science’s defining characteristics?

a. The willingness to admit ignorance. Modern science is based on the Latin injunction ignoramus – ‘we do not know’. It assumes that we don’t know everything. Even more critically, it accepts that the things that we think we know could be proven wrong as we gain more knowledge. No concept, idea or theory is sacred and beyond challenge.

b. The centrality of observation and mathematics. Having admitted ignorance, modern science aims to obtain new knowledge. It does so by gathering observations and then using mathematical tools to connect these observations into comprehensive theories.”28

If there’s any truth to the above, then Science Based Medicine’s focus verging on obsession with prior plausibility is actually completely unscientific. Rather than admit that we don’t know and then use empiricism to understand what’s happening in the world and make new theories, the prior plausibility of Science Based Medicine starts by saying ‘aren’t we clever, we may not know everything but we know enough’ and then uses this view to argue with, rather than understand, the data. The numbers say that patients get better with acupuncture compared to meds and that they’re put at far less risk of harm in the process. Let us tell you why the numbers are wrong according to our prior models.

The fact that science is based on the foundation of our awareness of our own ignorance is not a get out of jail free card to explain anything and everything as ‘possible’ or ‘scientific’. It is, however, a helpful reminder in the context of systematic reviews of thousands of randomised patients demonstrating an effective treatment for a common, debilitating condition for which satisfactory treatment options are scarce.

I hope you don’t mind all the questions and I’m really looking forward to increasing my knowledge of the Science Based Medicine approach to treating a clinical condition like migraine. From reading your blog and watching your videos, it was hard not to get the impression that you were more inclined to recommend treatments that don’t work well because you felt they should work in theory and recommend against treatments that do work, such as acupuncture, because in theory you felt that they shouldn’t based on your own narrow definition, which would be pretty unhelpful for patients (not to mention unnecessary, unethical and dangerous!). But, I’m sure you’ll be able to enlighten us on all the Science-y nuance that we’ve hitherto lacked the rigor to grasp.

]]>http://www.abetterwaytohealth.com/what-does-science-based-medicine-recommend-for-migraines/feed/11132“Prevention of Migraine”: Acupuncture is Conspicuous by its Unexplained Absencehttp://www.abetterwaytohealth.com/prevention-of-migraine-acupuncture-is-conspicuous-by-its-unexplained-absence/
http://www.abetterwaytohealth.com/prevention-of-migraine-acupuncture-is-conspicuous-by-its-unexplained-absence/#respondMon, 10 Jul 2017 20:36:48 +0000http://www.abetterwaytohealth.com/?p=1118Last month, JAMA published a clinical summary of treatments for the prevention of migraine, a reprint from a publication called the Medical Letter. What’s amazing about this summary is that it manages to include a mind-bogglingly diverse collection of treatments – everything from drugs to supplements to experimental head gadgets, from the virtually un-tested to treatments demonstrated to be ineffective ...

]]>Last month, JAMA published a clinical summary of treatments for the prevention of migraine, a reprint from a publication called the Medical Letter. What’s amazing about this summary is that it manages to include a mind-bogglingly diverse collection of treatments – everything from drugs to supplements to experimental head gadgets, from the virtually un-tested to treatments demonstrated to be ineffective in double-blind placebo controlled trials. And yet incredibly, this review does not mention acupuncture, one of the most thoroughly tested guideline recommended treatments of demonstrable efficacy, effectiveness and safety for the prevention of migraines.

Given that the purpose of JAMA’s review is to help inform clinicians about effective treatment options for migraines to better help their patients, my colleague Mark Bovey of the British Acupuncture Council and I felt that we’d be remiss not to draw attention to their oversight with a quick letter to the editor for publication in their next edition. Alas, we were informed today that the JAMA editorial staff didn’t feel that our letter was a ‘high enough priority’ for publication in their prestigious journal.

But it just so happens that I have a blog and can publish whatever the heck I like! So here it is, our response to Prevention of Migraines (this is a somewhat longer version that was drafted before I realised they have a 500 word limit!). It is a shame that JAMA felt that the subject of migraine prevention was important enough to cover but not important enough to cover thoroughly, omitting the treatment that according to copious clinical evidence has the potential to most benefit patients while simultaneously reducing risk. At any rate, enjoy!

“Prevention of Migraine”: Acupuncture is Conspicuous by its Unexplained Absence

We read your article on the prevention of Migraines with great interest and while not billed as a systematic review, we couldn’t quite tease out how you went about choosing recommendations for inclusion for educating clinicians. Obviously, it’s problematic to choose treatments in a completely arbitrary manner, which could leave out effective, evidence-based options while promoting treatments that have a poorer risk to benefit profile, thus undermining the entire purpose of the review. While the review mentions pharmaceutical, nutraceutical and physical approaches, both FDA approved and off-label, as well as effective and ineffective treatments, it fails to mention acupuncture, which has a stronger evidence base than most of the treatments recommended in your article. We wondered on what basis this was not included in your review informing clinicians about treatment options for migraine prophylaxis.

Initially, we thought it possible that this review was only covering pharmacological treatments. But then we noted the inclusion of butterbur, melatonin, riboflavin, and other non-drug supplements.

The review could have been focusing only on treatments taken orally, which could be why drugs and supplements, but not acupuncture, were mentioned. But the review includes a ‘transcutaneous electrical nerve stimulation device’ called Cefaly, which has undergone a single randomised placebo controlled trial consisting of 67 patients.1

It would have been logical that only FDA-approved treatments or treatments included in official clinical guidelines were considered for inclusion in the review. But most of the interventions mentioned don’t meet these criteria. Most Beta Blockers (metoprolol, nadolol and atenolol), the antidepressants (tricyclics and SNRIs), ACE inhibitors, NSAIDs, statins, and supplements, are not FDA-approved for migraine prevention and constitute off-label prescribing, as well not enjoying any official recommendation. So approval status does not seem to have weighed in to whether or not a treatment was mentioned. On the other hand, the FDA now recommends that doctors learn about acupuncture as a safe and effective pain treatment in order to reduce prescribing of opioids and acupuncture is recommended in the NICE clinical guidelines for the prevention of migraine. The only drugs recommended were topiramate, propanolol and gabapentin.2

One could approach the inclusion of treatments in such a review from a safety and tolerability perspective, but the vast majority of the treatments mentioned are poorly tolerated and frequently discontinued due to unpalatable side-effects. Likewise, many are not considered safe for use during pregnancy. On the other hand, acupuncture is considered to be a very safe treatment.

A review could be undertaken from the perspective of only including well-studied treatments. But some of the included treatments had only the flimsiest of evidence to support a recommendation. For example, the review mentions the combination of simvastin plus vitamin D in the prevention of migraine, based on a single study consisting of 57 patients, in a design that did not separate the effects of the statins from those of vitamin D, which has some evidence of effectiveness on its own. Incidentally, the lead authors of this study have applied for a patent for this treatment. On the other hand, the most recent Cochrane Systematic review of acupuncture for migraine prophylaxis includes 4,985 participants in 25 randomised controlled trials, firmly placing it amongst the most well-studied treatments for this condition.

Finally, in writing an informal review of treatments for preventing migraine, one could have approached the inclusion from the perspective of effectiveness or efficacy, focusing on the treatments that have been shown to work best for the condition under discussion, which would have been the logical choice if the intention was to educate clinicians on how to best help their patients. But some treatments mentioned have zero evidence of efficacy. For example, nortriptyline was mentioned as a frequently prescribed antidepressant with fewer side effects than amitriptyline. However, as a standalone treatment it has only been subjected to a single randomised placebo controlled trial, which found that it no more effective than placebo.3

On the other hand, strong peer-reviewed evidence support the use of acupuncture as an effective, efficacious and safe treatment for the prevention of migraine. According to the most recent Cochrane review, acupuncture is superior to no acupuncture (acute treatment only or routine care) and even to the diluted dose of acupuncture that masquerades as placebo.4 Of most clinical interest, though, was that acupuncture was more effective than prophylactic drugs (metoprolol, flunarizine and others), and with fewer adverse events. In terms of the proportion of patients whose headache frequency had at least halved after three months, this was 57% with acupuncture and 46% with drugs. In your own Internal Medicine journal, a recently published Chinese trial confirms the superiority of acupuncture over sham.

In summary, a review of treatments for migraine prophylaxis that fails to mention one of the best-studied, most effective and best tolerated treatments obviously does a great disservice to patients by misinforming clinicians about the best treatment options. This is why systematic reviews, and the clinical guidelines they inform, are considered the pinnacle of the evidence hierarchy. If there was a valid reason for this omission, we would be most interested to hear it because we couldn’t find one.

]]>http://www.abetterwaytohealth.com/prevention-of-migraine-acupuncture-is-conspicuous-by-its-unexplained-absence/feed/01118Is ‘The Butcher of New England’ Harming Patients with Undisclosed Conflicts of Interest?http://www.abetterwaytohealth.com/is-the-butcher-of-new-england-harming-patients-with-undisclosed-conflicts-of-interest/
http://www.abetterwaytohealth.com/is-the-butcher-of-new-england-harming-patients-with-undisclosed-conflicts-of-interest/#respondThu, 04 May 2017 21:02:53 +0000http://www.abetterwaytohealth.com/?p=1087Migraine is a common, debilitating condition that is notoriously difficult to treat. While conventional treatments offer a poor effectiveness versus safety profile, acupuncture has been demonstrated to be at least as effective if not more effective than medication with far fewer side-effects. For this reason, acupuncture is recommended in official evidence-based clinical guidelines such as the UK’s NICE Guidelines for ...

]]>Migraine is a common, debilitating condition that is notoriously difficult to treat1. While conventional treatments offer a poor effectiveness versus safety profile, acupuncture has been demonstrated to be at least as effective if not more effective than medication with far fewer side-effects2. For this reason, acupuncture is recommended in official evidence-based clinical guidelines such as the UK’s NICE Guidelines for Headaches.

However, Harvard neurologist Paul G. Mathew, who appropriately refers to himself as ‘The Butcher of New England’, seems to have a different opinion on the matter. In his recent blog post on the Harvard Health blog, which was riddled with questionable puns but largely devoid of demonstrable familiarity with the research literature on the subject under discussion, Dr Mathew argued that the benefits of acupuncture were small while the evidence for conventional treatments strong, that physical therapy is a great alternative to drugs even when it doesn’t work, and ended with a questionable anecdote pointing to an undisclosed financial conflict of interest, rather than a good-willed desire to inform patients on their treatment options, as a possible motivation for steering migraine sufferers away from a treatment with a proven record of efficacy and safety.

Modest at Best

Dr Mathew’s discussion of the literature on treatments for migraines was on the whole anecdotal and unreferenced, leading one to ask what exactly was the point of writing the post in the first place. (Get it? Point? POINT?! It’s a pun on acupuncture. Two can play this game).

However, in an uncharacteristic move, Dr Mathew dabbled with using an actual citation to support his prose, referring to a recent clinical trial on acupuncture for migraine3. According to Dr Matthew: “Twelve weeks after treatment, the acupuncture group had on average 3.2 fewer attacks per month, the sham acupuncture group had 2.1 fewer attacks per month, and the wait-list group had 1.4 fewer attacks per month. These results are modest at best.”

So compared to sham needling, which is an active control with specific effects in the treatment of migraine4, true acupuncture was significantly more effective at reducing migraines at all time points while sham acupuncture was not significantly different from the waitlist control. Of course, normally, evidence-based practitioners prefer to use systematic reviews where available over individual studies. The most recent Cochrane review found that for reduction in headaches, acupuncture was associated with an effect size of 0.19 compared to active sham needling control 5, which to compare is greater than the effect size of SSRIs compared to placebo.6 Compared to usual care, the effect size is -0.56 in favor of acupuncture.

At 16 weeks, 200mg/day of Topiramate is associated with a reduction of 1.08 migraines per month7, whereas acupuncture has a 1.10 migraine reduction compared to sham needling.

Another migraine treatment, Botox injections, has even weaker support for its use. The PREEMPT trials, which were multi-armed Phase III trials funded by Allergan, the makers of Botox, found the following results for reduction in headaches per month: at 24 weeks, the Botox group had 5.2 fewer attacks and the placebo group had 4.9 fewer attacks, a difference of less than half a headache per month. At 56 weeks, the Botox group had 7.4 fewer attacks and the placebo group had 7.5 fewer attacks, a difference of precisely zero. Nada. Zilch.

So, Dr Mathew, if you describe the difference in reduction of headaches between acupuncture and active sham needling to be “modest at best,” then precisely how would describe the total lack of difference in headache reduction with Botox compared to placebo?

Butchering the Evidence on Standard Treatment

What’s interesting about the drugs used in the prevention of migraine, whether it’s an ACE inhibitor, alpha-blocker, beta-blocker, SSRI, serotonin agonist or tricyclic antidepressant, is that they all have something in common: none of them are actually migraine medications. They all fall into the category of ‘off-label prescribing.’ That’s when a drug approved for one use, such as an anti-depressant, is used for another entirely different use, such as migraine prevention, which it hasn’t been licensed or approved for. This situation arises because there aren’t really any medications that work very well for preventing migraines. Since this is pretty much common knowledge amongst clinicians, it was particularly surprising that as Dr Mathew argued against using acupuncture while pointing to evidence of its efficacy, he claimed that there’s good evidence for standard treatment, without pointing to any data at all.

Dr Mathew, not to be slowed down by actually reading the literature before summarizing it, tells us: “In general, the effectiveness of standard treatment (medication and injectable therapies) is supported by much stronger scientific evidence than acupuncture, including large clinical trials with thousands of subjects.” Fascinating. A 2015 meta-analysis8 of all drugs for the prevention of migraine, which included 126 randomized placebo-controlled clinical trials, found that the number of participants included in the studies was 112 on average, ranging from 9 to 783, making one wonder, pray tell, exactly which clinical trials with ‘thousands of subjects’ providing strong ‘scientific evidence’ for treating migraines with drugs Dr Mathew is referring to . . .

The results of this review are as follows: most of the drugs that are regularly used have no effectiveness beyond placebo. Drugs with at least 3 trials that were more effective than placebo for episodic migraines were as following:
– Amitriptyline: SMD: -1.2 (-1.7 to -0.82)
– Flunarizine: -1.1 headaches/month (-1.6 to -0.67)
– Fluoxetine: SMD: -0.57 (-0.97 to -0.17)
– Metoprolol: -0.94 headaches/month (CI -1.4 to -0.46)
– Pizotifen: -0.43 headaches/month (CI -0.6 to -0.21)
– Propranolol: 1.3 headaches/month (-2.0 to -0.62)
– Topiramate: -1.1 headaches/month (-1.9 to -0.73)
– Valproate: -1.5 headaches/month (-2.1 to -0.8)

So the studies on drugs that reported the results in terms of headaches per month had about the same advantage or perhaps less over placebo pill as acupuncture had over active sham control. And since the drugs were compared to an inert placebo and the acupuncture was compared to an active control, then it’s likely that acupuncture’s effectiveness is underestimated.

If that were the case, we’d expect acupuncture to outperform drugs when tested head to head, which is precisely what the literature shows.

A randomized trial of acupuncture versus topiramate9, an anticonvulsant often used to treat migraines, demonstrated that acupuncture resulted in a significantly larger decrease in moderate/severe headaches (from 20.2 down to 9.8 versus 19.8 to 12 in the topiramate group). Additionally, acupuncture was more effective than topiramate for all secondary outcomes, such as pain intensity and quality of life. While adverse events occurred in 66% of the topiramate group, they only occurred in 6% of the acupuncture group, demonstrating a far superior benefit to risk profile for acupuncture.

A 2013 study evaluating acupuncture vs valproic acid, another anti-epileptic drug, showed that at 6 months, pain intensity was lower in the acupuncture group, pain relief was greater, and the acupuncture group was taking significantly less acute medication (Rizatriptan). The rate of adverse events in the group given valproic acid was 47.8%; in the acupuncture group it was 0%.10

A recent Cochrane Systematic review confirms the findings of these studies. Compared to drugs, acupuncture is associated with -0.49 fewer migraine attacks at 8 weeks, -0.32 fewer migraines at 4 months, and -0.31 migraines 3.5 to 6 months after randomization compared to drugs. All results are statistically significant.

While self-styled acupuncture “Skeptics” (those who argue that acupuncture doesn’t work regardless of considerable evidence to the contrary) are quick to point out that head to head comparisons are biased because they are unblinded, researchers and clinical experts are quicker to point out that so is real life, where the patients are. Acupuncture’s superiority over sham and its many known biochemical mechanisms demonstrate specific effects. But of course, all of this is purely academic; head to head studies are the ones that tell you which treatments are most likely to benefit real patients in the real world comparing the treatment options that they are actually faced with, provided in the way that they would actually receive the treatment. The best evidence shows that acupuncture is more effective than drugs.

Side-effects?

“Side effects are not just limited to medications; procedures can also have negative effects,” Dr Mathew reminds us. Excellent point! According to an analysis of the safety and tolerability of Botox for chronic migraine, adverse events (AEs) were reported in a whopping 74% of those who received Botox. In fact, neck pain is such a common side-effect of the treatment that it results in unblinding in trials, as subjects know whether or not they’ve received the real deal based on how much pain they’re in afterwards.

Serious adverse events, which “were any that resulted in death, a life-threatening event, hospitalization (initial or prolonged), disability, a congenital anomaly or a medical event that could require medical or surgical intervention to prevent the above outcomes” was reported in 5.4% of those who were injected with Botox. The most common serious AE was (wait for it . . .) migraine. It’s unclear whether the common occurrence of migraines triggered by Botox treatment were classed as serious AE’s simply by causing disability or if a significant number of test subjects had migraines caused by Botox that were so severe they required hospitalization. Either way, causing serious migraines seems like sort of a counter-productive effect for a migraine treatment.

So what the data suggests is that not only does Botox not seem to reduce migraines compared to placebo, but the data shows that it actually causes them.11

After recommending against acupuncture based on a high-quality study that supports its efficacy, Dr Mathew has this advice for those who want to steer away from medication: “For those averse to medications, physical therapy is a great alternative — one based on actual human anatomy and scientific principles. My patients often complain that they do not feel significantly better after the five to 10 sessions of physical therapy that insurance companies typically approve. I advise them that the true benefit of physical therapy comes when the stretching and strengthening routines taught by the therapist are continued at home on a long-term basis.”

So physical therapy is ‘a great alternative’, even though a recent systematic review failed to show any effect on reducing migraines compared to control12 and even when his patients are telling him that it’s not working.

What would possibly compel Dr Mathew to write this?

The literature shows that acupuncture is an effective and safe treatment for migraine prophylaxis; indeed, it is one of the only ones clinical experts know of. It is more effective than sham needling, demonstrating specific effects and it’s more effective and safer than drugs, demonstrating that it should be offered as a first-line treatment and often is.

So why would Dr Mathew write a largely unreferenced blog post on Harvard’s Health Blog based on anecdote, opinion and conjecture that’s directly contradicted by the medical literature?

A possible clue comes at the finale of the piece, where we learn that a) Dr Mathew provides Botox injections for migraines, b) that he trains others to perform the procedure and c) that he thinks it’s appropriate to mock patients about how painful this procedure is (the safety data confirms that pain is a common result of the treatment and teasing patients about it just seems cruel).

Ok, so he’s a bit biased. He provides Botox and wants to rib the competition. Not very professional, appropriate or ethical, but we all get our kicks in different ways. It’s not like he’s received payment from Allergan, I mean that would be highly unethical not to mention totally inappropriate to write something so libelous and inaccurate without making his conflicts of interest crystal clear.

I suppose we’ll never know if Dr Mathew would have taken it upon himself to steer patients away from a safe and effective treatment for a debilitating neurological condition towards a treatment that suffers from lack of evidence and a risky side-effect profile if he wasn’t financially incentivized to do so. One wonders if it is even appropriate for someone who is receiving money from the pharmaceutical industry to be writing about a non-pharmacological treatment such as acupuncture at all when they apparently lack any familiarity with the subject matter.

But one thing is crystal clear: Harvard, for the sake of public health and academic integrity, a highly visible conflict of interest declaration needs to be added to the top of this ‘blog post’ post-haste.

]]>http://www.abetterwaytohealth.com/is-the-butcher-of-new-england-harming-patients-with-undisclosed-conflicts-of-interest/feed/01087Wikipedia, We have a problemhttp://www.abetterwaytohealth.com/wikipedia-we-have-a-problem/
http://www.abetterwaytohealth.com/wikipedia-we-have-a-problem/#respondTue, 27 Dec 2016 08:54:44 +0000http://www.abetterwaytohealth.com/?p=984In a nutshell: Acupuncture has been increasingly embraced by conventional care as an efficacious treatment for a variety of conditions. Evidence of this support comes from recommendations for acupuncture in numerous medical guidelines, Cochrane systematic reviews demonstrating clinical effectiveness, and an explosion of research interest into acupuncture’s effectiveness and mechanisms of action. All of this support notwithstanding, the article devoted ...

]]>In a nutshell: Acupuncture has been increasingly embraced by conventional care as an efficacious treatment for a variety of conditions. Evidence of this support comes from recommendations for acupuncture in numerous medical guidelines, Cochrane systematic reviews demonstrating clinical effectiveness, and an explosion of research interest into acupuncture’s effectiveness and mechanisms of action.

All of this support notwithstanding, the article devoted to acupuncture on Wikipedia, the most accessed source of medical information on the internet and supposedly an unbiased source of curated information that anyone who follows Wikipedia’s policies can edit, reflects a somewhat different perspective. The page, controlled by a group of staunch anti-acupuncture ‘pseudoskeptics’ – insists that the mainstream support for acupuncture from the medical and scientific community doesn’t exist, even when it is presented to them, and presents their subjective minority opinion as the dominant one. They mainly do this by a) ignoring high-quality sources that contradict their perspective and b) systematically intimidating, bullying and banning anyone who dares to say otherwise. This state of affairs is problematic on many levels, not least of which because it directly impedes access to informed health care choice. I’m hopeful that an open discussion of the evidence and my own recent (and short!) experience as a Wikipedia editor before being indefinitely banned for challenging their version of consensus can result in an improvement to the Wikipedia article vis-à-vis how well it reflects objective reality and better enforcement of Wikipedia’s anti-bullying guidelines.

Making the case for acupuncture’s mainstream support

The pejorative designation of ‘pseudoscience’ is defined by Wikipedia in reference to what is perceived as scientific and medical consensus. To say that ‘acupuncture is pseudoscience’, as the Wikipedia article flatly states, is to say that acupuncture enjoys little to no mainstream medical and scientific support. The administrators and (remaining) editors of the Acupuncture article on Wikipedia have claimed just that. Sure, acupuncture does have some fans, but these people are universally gullible morons who wouldn’t know a null hypothesis if it poked them in the eye, so their argument goes. Anyone with a medical degree and two brain cells to rub together will concur that acupuncture is woo-tastic, pseudo-scientific quackery.

Of course, any statement about what scientific consensus does or does not show needs to be backed by suitable references and Wikipedia provides specific guidance on what it considers to be Reliable medical sources (or MEDRS, as they’re known in Wiki-speak):

“Ideal sources for biomedical information include: review articles (especially systematic reviews) published in reputable medical journals; academic and professional books written by experts in the relevant fields and from respected publishers; and guidelines or position statements from national or international expert bodies.”

In other words, one can reliably demonstrate that acupuncture enjoys mainstream scientific and medical support (and does not meet Wikipedia’s definition of pseudoscience) by providing review articles and position statements by expert bodies.

So what do medically reliable sources say on the subject of mainstream medical support for acupuncture?

Acupuncture is recommended in conventional medical guidelines

According to Tgeorgescu, who holds a Masters in Philosophy, is a Member of the Dutch Society against Quackery and long-time Wikipedia enforcer, not only is there no mainstream scientific support for acupuncture (reference not provided), but providing evidence that there is support is grounds for being banned from Wikipedia.

Medical guidelines produced by medical and clinical organisations constitute one of the most direct types of evidence we have to assess ‘medical consensus.’ Acupuncture is recommended by the following mainstream Medical Guidelines and Organisations

The World Health Organisation has developed a list of 27 conditions for which it recommends acupuncture after its evidence review1

The U.S. Department of Health and Human Services – National Institutes of Health Guidance on Low Back Pain recommend acupuncture6

The State of Colorado Division of Workers’ Compensation Medical Treatment Guidelines for Low Back Pain recommends acupuncture7

The Institute for Health Economics Evidence-Informed Primary Care Management of Low Back Pain Alberta, Canada recommend a course of acupuncture for chronic low back pain 8

Scotland’s National Clinical Guideline for the Management of chronic pain recommends acupuncture for low back pain and osteoarthritis, characterising the strength of the evidence as Grade A (the highest support available)9

The National Institute for Health and Care Excellence (NICE) recommends a course of acupuncture for the prevention of migraines and tension-type headaches. In fact, acupuncture is the only treatment recommended for the prevention of tension-type headaches.

The 4th Edition of “Acute Pain Management: Scientific Evidence,” Produced by the Australian and New Zealand College of Anaesthetists and Faculty of Pain Medicine, found Level I evidence for acupuncture for five different clinical indications 10

Wow, the WHO, the AHRQ, NICE and the Joint Commission, pretty much the ‘who’s who’ of prestigious mainstream medical consensus building institutions, all recommend acupuncture? I mean, a couple of acupuncture-recommending guidelines would have been sufficient to demonstrate that the ‘pseudoscience’ designation was controversial and the Wikipedia article needs to be changed to reflect this undisputed reality; the number and strength of the recommendations here are vastly surplus to requirement for that purpose. Sure, there are a few guidelines recommending against acupuncture11, but these guidelines simply provide support of another opinion and obviously don’t negate the existence of all the guidelines clearly supporting acupuncture.

So the most respected conventional medical organisations in the world, after rigorous scientific review, have created consensus time and again around recommending acupuncture for a variety of treatments. These guidelines ubiquitously steer clear of evaluating or recommending Angel Healing, Reiki, or Crystal therapy (no disrespect). The very existence of these guidelines automatically renders the statement “acupuncture is pseudoscience” completely invalid. They provide indisputable evidence that meaningful parts of the mainstream medical community recommend acupuncture. While one is welcome to discuss the quality or methods of the guideline development, one cannot dispute their existence.

Cochrane Reviews

According to Hob, every single Cochrane Review of acupuncture performed has found no significant difference between Acupuncture and sham (no reference provided). In reality, a number of Cochrane reviews have found acupuncture to be superior to sham (for example, migraine, tension-type headache). These reviews are referenced on the Wikipedia acupuncture page and on the very talk page where Hob has written his comment but Hob seems to prefer to ignore their existance.

While the guidelines listed above are surplus to requirement for demonstrating meaningful mainstream consensus for acupuncture’s recommendation, Cochrane Reviews are considered amongst the highest levels of evidence in medicine and provide additional high-quality support.

A Cochrane Systematic Review published in April, found that for the prevention of tension-type headaches, acupuncture was more effective than usual care and pain medication (48% of those who received acupuncture vs 19% of those who received meds had a positive response) and acupuncture was more efficacious than sham (50% of acupuncture recipients vs 43% of patients who received sham acupuncture had a positive response)12

Another Cochrane Review for Acupuncture in the treatment of Migraines found that acupuncture is far more effective than usual care and also more effective than sham needling.13

Acupuncture was found to be superior to sham, waitlist and physical therapy for peripheral joint osteoarthritis14

Acupuncture is superior to usual care in the treatment of fibromyalgia 15

Acupuncture is superior to usual care for cancer-related pain and auricular (ear) acupuncture was found to be superior to placebo for chronic neuropathic pain related to cancer16

Acupuncture was found to be superior to anti-spasmodic drugs, which themselves have been shown to be better than placebo, in the treatment of Irritable Bowel Syndrome

Mechanism research

According to Hob Gadling, long-time Wiki-editor, admin, and fighter of Pseudoscience, ‘acupuncture is clearly a magic practice and has neither a viable mechanism nor evidence on its side” (references not provided). When provided high-quality evidence of mechanism (peer-reviewed evidence syntheses) and efficacy (for example, Cochrane Reviews), he has failed to address these but maintains his opinion: definitely pseudoscience. And not only does he think it’s pseudoscience but according to him, this is also the medical and scientific consensus (reference not provided).

The International Review of Neurobiology published a 363-page evidence review of acupuncture’s mechanisms and clinical areas where acupuncture has strong evidence of effectiveness. The IRN only publishes reviews on conventional and mainstream medical neurological subjects 17

A recent review published in the Neuroscientist has summarised the evidence for acupuncture’s effects through purinergic signalling.18 It notes: “The seminal hypothesis of Geoffrey Burnstock and the astounding findings of Maiken Nedergaard on the involvement of purinergic signaling in the beneficial effects of acupuncture fertilized the field and led to an intensification of research on acupurines.” Incidentally, Wikipedia tells us that the “The Neuroscientist is a peer-reviewedacademic journal that publishes papers in the field of Neurology . . . aimed at basic neuroscientists (sic), neurologists, neurosurgeons, and psychiatrists in research, academic, and clinical settings, reviewing new and emerging basic and clinical neuroscience research. The journal evaluates key trends in molecular, cellular, developmental, behavioral systems, and cognitive neuroscience in a disease-relevant format.” The article must have forgotten to mention its studies of quackery and pseudoscience.

A recent review by Dr Thomas Lundeberg, a rehabilitation physician and former Professor of physiology at the Karolinska Institute, one of the top medical schools in the world, and Irene Lund, adjunct at the Karolinska Institute’s department of Department of Physiology and Pharmacology, summarises acupunctures mechanisms thusly:

Increasing use in Mainstream settings

Acupuncture has been used in the US military for over a decade and its use is expanding. 8 out of the top 10 rated cancer hospitals in the United States offer acupuncture treatment on site. Following trials that showed that acupuncture was twice as effective as usual care for low back pain relief, it is covered by national health insurance in Germany.

Ok, so there clearly are mainstream medical researchers and health-care policy makers from some of the most respected institutions in the world who do officially endorse acupuncture, as suitably demonstrated above. Surely when presented with all of this evidence, the pseudo-Skeptical admins would have to concede despite their own personal feelings that significant parts of the mainstream medical establishment do recommend acupuncture . . .

“Acupuncture is Pseudoscience,” says Wikipedia

Acupuncture clearly enjoys a staggering amount of mainstream scientific support. So how does one decide exactly what pseudoscience is?

Well, Wikipedia has a specific policy on when it is appropriate to apply the label. We find this policy under the content guideline on something called “Fringe Theories.”

In other words, whether or not a theory is ‘fringe’ depends on the ‘prevailing’ or ‘mainstream’ views of the field. If a theory (or treatment) enjoys mainstream scientific support, it is neither fringe nor pseudoscience. Wikipedia’s guidance on the matter goes even further to articulate what can and cannot be branded with the unfortunate mark of pseudoscience. The guidance describes the grand ‘spectrum of fringe theories’ thusly:

“Not all pseudoscience and fringe theories are alike.” Oh, no. “In addition, there is an approximate demarcation between pseudoscience and questionable science, and they merit careful treatment.

Pseudoscience: Proposals that, while purporting to be scientific, are obviously bogus may be so labeled and categorized as such without more justification. For example, since the universal scientific view is that perpetual motion is impossible, any purported perpetual motion mechanism (e.g. Stanley Meyer’s water fuel cell) may be treated as pseudoscience. Proposals which are generally considered pseudoscience by the scientific community, such as astrology, may properly contain that information and may be categorized as pseudoscience.

Questionable science: Hypotheses which have a substantial following but which critics describe as pseudoscience, may contain information to that effect; however it should not be described as unambiguously pseudoscientific while a reasonable amount of academic debate still exists on this point.”

Taking into account all of the medical guidelines, position papers, Cochrane reviews and increasing research interest, acupuncture very clearly falls into the latter category. Yes, acupuncture does court a small but vocal group of detractors – these groups are usually distinguishable by a variant of the word ‘Skeptic’ in their title (as in Guerilla Skepticism on Wikipedia, a group devoted to training and sending groups of self-styled ‘Skeptics’ to edit Wikipedia articles to be more in line with their particular world-view), a most ironic use of the word ‘Science’ in their name (as in Science-Based Medicine) and can be seen to frequently use terms like ‘woo’ and ‘quackery,’ which are almost entirely absent from the vocabulary of the majority of those involved with healthcare and scientific research. They almost exclusively reference narrative opinion pieces by other Skeptics, such as this cherry-picking tired old hag, who’s seen more action than a brothel in a seaport, rather than primary or valid secondary sources such as Cochrane, displaying an embarrassing lack of familiarity with Ye Olde Evidence Hierarchy. These groups engage, according to the mainstream medical community, in something called ‘pseudoskepticism‘ and are to rational scientific inquiry what religious extremists are to mainstream religion and spirituality.

Denial: Not Just a River in Egypt

Having been presented with Wikipedia-appropriate high-quality medical references, including the medical guidelines, systematic reviews, and mechanism research syntheses listed above, how does this reliable information about acupuncture mesh with the skeptical world-view? Well, it doesn’t.

So how do the admins on the acupuncture page justify continuing to present their view as the undisputed consensus view in the face of so much evidence to the contrary? I’ve observed a number of well-worn patterns, here are the most common:

Label supporters of Acupuncture as Idiots

According to user ‘Hob Gadling’:

“Acupuncture is clearly a magic practice and has neither a viable mechanism nor evidence on its side. Still, it is used by lots of folks who do not know how to tell valid methods from superstition. Those people clearly do not agree that acupuncture is pseudoscience, but the situation is exactly the same as with other pseudosciences: their proponents do not agree that they are pseudoscientists. We get that all the time, for instance from Intelligent Design proponents.” 5:07, 14 December 2016 (UTC)

Yes, superstitious folks unfamiliar with valid research methods, like those morons at Harvard, the utter simpletons found at The National Institute of Neurological Disorders and Stroke and the irredeemable idiots over at the Mayo Clinic all recommend acupuncture.

User ‘Guy’ tells us: “At this point everyone other than the pathological believers is basically ready to move on. The great tragedy of science: the slaying of a beautiful hypothesis by ugly fact. Guy 23:18, 15 December 2016 (UTC)”

Fascinating. And yet, according to the recent study produced by Harvard and IBM, “Acupuncture research has grown markedly in the past two decades, with a 2-fold higher growth rate than for biomedical research overall. Both the increases in the proportion of RCTs and the impact factor of journals support that the quality of published research has improved. . . These findings provide a context for analyzing strengths and gaps in the current state of acupuncture research, and for informing a comprehensive strategy for further advancing the field.”20 Looks like the ‘pathological believers’ at Harvard are developing a comprehensive strategy to further advance acupuncture.

“. . . Of course, your statements do not become true by repeating them. Acupuncture is not “mainstream”, and you will not find a reliable source that says it is. . . –Hob Gadling 21:28, 14 December 2016 (UTC)

Difficult to know quite how to respond, given that we had already presented dozens of very reliable sources that said just that (my mistake for thinking that repetition would somehow help the reality sink in).

“It’s implausible, there’s no remotely plausible mechanism, most of the claims made for it are patent nonsense, it’s practiced by people who for the most part have absolutely no valid medical training and do not use any kind of infection control techniques, and it shows absolutely no sign of getting its house in order . . . Guy 09:05, 22 December 2016 (UTC)

Fact-check: Globally, the majority of those who practice acupuncture are licensed doctors with medical degrees, including over 35,000 MDs outside of South East Asia.

Invent your own evidence

“Science is not done by majority vote, it is done by data and their publication in scientific journals. Gather all the Cochrane meta-analyses done about acupuncture and show that they agree that acupuncture is better than placebo, and you win. You can’t because they all say the opposite, so you lose. Bye. —Hob Gadling 23:20, 13 December 2016 (UTC)”

Fact check: Multiple Cochrane reviews show that acupuncture is better than sham acupuncture and much better than usual care. But because the public are being misinformed about their healthcare choices by a source they mistakenly trust, you’re right, we all lose.

User Alexbrn tells us: “the enlightened basis of what we do is the real world: scientific plausibility, common sense & reason. Acupuncture boosters, Bigfoot spotters, 9/11 conspiracists, cultists etc. don’t like this but it’s their problem with reality which causes friction, not Wikipedia itself. If exceptionally strong sources appear, then we can follow them: until then, Wikipedia shall take a properly skeptical stance.” 09:56, 29 October 2016 (UTC)

“I think it is fair to say by now that there is no robust evidence that acupuncture works for anything, and any area where the balance of P=0.05 is still positive, is an artifact.” Guy 20:24, 14 December 2016 (UTC)

“there is no good evidence it works for most conditions, and all we have left are a handful of conditions where counting the papers shows a majority passing P=0.05 on subjective endpoints (which is entirely consistent with the expected 5% false positive rate inherent in P=0.05) . . .” Guy 09:05, 22 December 2016 (UTC)

Translation: the Cochrane Reviews that demonstrate that acupuncture is superior to sham and usual care are wrong. Because Guy says so. Of course, all of the high-quality reviews of medical interventions ever gathered have an equal chance of being wrong – any of these results could equally be ‘artifacts.’ Thus using Guy’s logic, we would chuck out everything we think we know about medical science. Guy is happy to delete the entire corpus of medical knowledge in order to maintain the view that acupuncture doesn’t work, demonstrating what lengths people are willing to go to in order to protect a cherished belief.

“However there are ample sources in this article that acupuncture is pseudoscience and that it has no scientific base whatsoever. Carl Fredrik 00:23, 16 December 2016 (UTC)”

“”Wikipedia is heavily biased for mainstream science” (or mainstream anything) is exactly how I’d expect an encyclopedia to work. On science subjects, Wikipedia should present articles with a balance that is supported by reliable peer-reviewed sources that exercise proper editorial control and are based on accepted scientific method – mainstream science by definition. (talk) 08:23, 21 December 2016 (UTC)” says User “Boing! said Zebedee”, while failing to acknowledge the panoply of reliable peer-reviewed sources that exercise proper editorial control and are based on accepted scientific method supporting acupuncture’s efficacy.

“The comparison is to the point: although propagated by quackademics, both therapeutic touch and acupuncture lack mainstream scientific support. That’s the reality of mainstream science. So, if you claim that they have lots of mainstream scientific support, that’s a mystification.” Tgeorgescu 20:51, 21 December 2016 (UTC)

Sure, Tgeorgescu, I have ‘mystified’ over a dozen medical guidelines into existence. I’m just that good.

It only works for pain

A user called ‘Roxy the dog’, who agrees that acupuncture is pseudoscience, decisively breaks out from the pack and acknowledges the existence of the scientific resources that elucidate some of acupuncture’s biological mechanisms. His/her comment: “Doesn’t the hatted list of ‘sources’ demonstrate a pain response, and nothing more? 12:37, 15 December 2016 (UTC)”

User ‘Alexbrn’, ferociously anti-acupuncture, shares a similar sentiment: “Really? Isn’t it rather that they’re pretty much firmly decided that acupuncture is ineffective overall, with a possible exception in one area: pain relief? 17:07, 14 December 2016 (UTC)”

Yeah, because that would be useless. An effective treatment for pain. Roxy and Alex agree that acupuncture lacks any useful function whatsoever and that it be branded as “pseudoscience” because all it does is provide efficacious pain relief <facepalm>.

When all else fails, silence your critics

As a new editor, I thought that presenting new high-quality medical references to the discussion on acupuncture’s Talk page in order to ensure that the article reflected the most up to date scientific perspective would be appreciated. Boy was I wrong.

“@Ellaqmentry: You have done absolutely nothing right. A cursory inspection of the talk page archives should have shown you that your arguments have been made and rejected for years. . . if you persist in making those comments, you are likely to become another (editor banned from Acupuncture) . . .” — Arthur Rubin 16:57, 19 December 2016 (UTC)

In response to these comments, I asked Arthur to please not bully me. He responded by vandalising my user page, removing the ‘new user’ tag I had put there so that folks would know I was new to the community.

“You have to take into account that Wikipedia is heavily biased for mainstream science. Those who manifestly work against this bias are subjected to discretionary sanctions.” Tgeorgescu 23:02, 20 December 2016 (UTC)

“Let me put it simply: if you continue to claim that acupuncture has mainstream scientific validation, you have no future as an Wikipedia editor.” Tgeorgescu 21:05, 21 December 2016 (UTC)

“To reiterate and clarify: if you continue to claim that acupuncture has mainstream scientific validation, you have no future as an Wikipedia editor. That is true not “regardless of whether or not it actually has”, it is true because it hasn’t. . . ” Guy 23:04, 21 December 2016 (UTC)

We Follow the Sources

So what’s the other side of this coin? How do the acupuncture article admins justify branding acupuncture pseudoscience according to indisputable medical consensus in the face of so much evidence to the contrary? The comments you are about to read were made with the benefit of the above research references.

The Acu-Wiki admins have provided two sources that they feel prove without a shadow of a doubt that the medical and scientific consensus pretty much unanimously agree that acupuncture is pseudoscience: the first is an introductory undergraduate textbook for non-science majors.21 The second is a primer on science in education.22 Neither of these sources is peer-reviewed, referenced or bills itself as a representation of scientific or medical consensus.

But let’s hear what the pseudoskeptical admins say about the strength of their sources. In each of the following, the author is referring to these two non-medical, non-referenced, non-peer-reviewed books.

“No, those sources are fine.” 19:26, 29 October 2016 (UTC) Says Carl Fredrik, a 4th year medical student, when questioned about their validity.

User Someguy1221 was slightly more circumspect about the sources supporting acupuncture as pseudoscience: “We subject sources on the side of pseudoscience and pseudomedicine, such as acupuncture, to a far higher degree of scrutiny than we do sources on the side of actual science and medicine. Some sources used in the article may not meet the strict criteria of MEDRS, but no one cares, because these do not say anything controversial – if we were to exclude them in exchange for actual MEDRS-compliant sources, the article content would not change significantly. But articles that find something promising in acupuncture and appear on their face to be MEDRS compliant, on the other hand, are basically universally found to have serious problems that invalidate their reliability.” 08:50, 29 October 2016 (UTC)

Translation: because there’s nothing controversial about saying that acupuncture is pseudoscience (aside from the fact that Wikipedia editors have been arguing about this since 2001) we do not have to use appropriate references to support the statement. Conversely, high quality, appropriate references supporting acupuncture’s acceptance or efficacy are flawed because they support acupuncture. Ah, Someguy1221, your head sounds like a fascinating place to live.

But by far the largest advocate of ‘the sources,’ Alexbrn, who has a PhD in English but no scientific or medical background to speak of, was downright exuberant about the strength of the aforementioned sources.

“Most of these dodgy areas have studies trying to validate them (cf homeopathy and osteopathy). As far as pseudoscience goes, we have two excellent sources that address the categorisation and are explicit. Acupuncture is pseudoscience. Wikipedia reflects such sources. “Alexbrn 12:32, 15 December 2016 (UTC)

“Incorrect. Both sources, which are strong WP:MEDRS23 assert that acupuncture is pseudoscience. We follow such sources, not the musings of random WP:SPA wikipedia editors. Alexbrn 14:42, 15 December 2016 (UTC)

“Whatever way you look at it, reliably-published medical books (referring to the two non-medical books above) which specifically consider the non-scientific are the best possible sources available. To find sources on the question of acupuncture and its relation to pseudoscience, try searching collections with the search terms “acupuncture” and “pseudoscience” maybe? All you are doing is producing fallacious arguments and hand-waving. Stick to following sources and all shall be well. Alexbrn 15:01, 15 December 2016 (UTC)”

“More hand-waving and fallacy. We have two top-rate sources that are bang on topic, and they are explicit in what they say. No amount of trying to question how they came to be, to personalize the matter, or to big up your own credentials is remotely relevant to the formation of consensus here, which is based exclusively on the WP:PAG. Wikipedia reflects what the best sources say; they say acupuncture is pseudoscience, so Wikipedia shall too. It’s really very simple. The only thing that might give pause is an equally strong source which explicitly considered the pseudoscience categorisation and rejects it.” Alexbrn 15:52, 15 December 2016 (UTC)

“This “majority view” stuff is baloney. The sources we have which consider the pseudoscience question place acupuncture in that category. Show me sources that consider the question which don’t. Lots of nonsenses are studied at Masters level and beyond: homeopathy, ayurveda, cranial therapy … these novel arguments are irrelevant in any case since we follow the sources.” Alexbrn 15:56, 15 December 2016 (UTC)

“Luckily we have excellent sources which directly consider acupuncture’s relationship to pseudoscience. They tell us it is pseudoscience – Wikipedia accordingly follows because that is the way this place works.” Alexbrn 16:27, 15 December 2016 (UTC)

“Besides, my personal opinion counts for nothing: what matters is what our good sources say on the pseudoscience question. Here, they’re nice and clear.” Alexbrn 18:01, 15 December 2016 (UTC)

“On pseudoscience, all the sources we have agree, and nobody has produced any RS (reliable sources) in opposition . . . ” Alexbrn 18:50, 15 December 2016 (UTC)

And, my personal favourite:

“We’re citing two high-quality medical textbooks focusing directly on the topic of pseudoscience. Despite the fact we don’t need such super-strength sources, we have them and we use them. We reflect what our sources say; OTOH the “personal” WP:PROFRINGE preference here is yours.” 10:26, 29 October 2016 (UTC)

Super-strength, high-quality medical textbooks. Wow. I think the only accurate descriptor in that sentiment is “books”. It was shortly after this discussion about the super-strength medical textbooks that Alexbrn would recommend on the administrator forum that I be indefinitely banned from editing on Wikipedia and the community, already having banned anyone else of a different opinion, would agree.

Wikipedia, the Encyclopedia that anyone can edit, so long as you don’t violate consensus.

But surely with Wikipedia being the ‘Free Encyclopedia’ that anyone can edit, the contents of the acupuncture page reflects the consensus opinion of the global community of English-speaking editors who have participated in its development. If there were reasonable evidence that the contents were incorrect, one could just present this and have it changed, no?

Sadly this is not the case.

13 December 2016: I created my first and only editor account on Wikipedia.

13 – 19 December 2016: I made a total of 20 comments on Wikipedia’s acupuncture discussion page. I made no edits to the Acupuncture article itself. My comments were respectful, relevant, and referenced.

19 December 2016: An administrator who goes by Someguy1221, created a new notice in the administrator’s noticeboard accusing me of being a “Sock-puppet”, which is when an editor who has been banned from editing creates a new account to circumvent the ban.

“Before opening an investigation, you need good reason to suspect sock puppetry.

Evidence is required. When you open the investigation, you must immediately provide evidence that the suspected sock puppets are connected . . . You must provide this evidence in a clear way. Vaguely worded submissions will not be investigated. You need to actually show why your suspicion that the accounts are connected is reasonable.”

No evidence was provided for his allegation that I’m a Sock, which is a violation of Wikipedia’s policy on making such an accusation.

Someguys1221 also accused me of being a “Point of View Pusher,” which is where someone makes an ‘aggressive’ presentation of a particular point of view in a Wikipedia article; I never made a single edit to any Wikipedia article, aggressive or otherwise.

For my alleged crimes, Someguy1221 recommended that I be indefinitely banned from using Wikipedia or Topic banned from participating in the editing of the Acupuncture article.

19 December 2016: Guy, a Wikipedia administrator who disagreed with my perspective on acupuncture’s mainstream support, indefinitely blocked me from editing Wikipedia articles. Given his involvement in the discussion, this was a clear violation of Wikipedia’s policies which state that admins who are involved should not do the blocking. After this, he had another administrator block me instead.

Since this time, I have been indefinitely banned from editing any part of the Wikipedia project, even though I have not violated a single one of Wikipedia’s policies in either letter or spirit. It seems that simply making the argument that acupuncture enjoys mainstream medical support is sufficient grounds for being banned from editing Wikipedia.

Unfortunately, my experience of being banned for providing high-quality evidence that acupuncture enjoys mainstream support is not an isolated incident. A Wikipedia editor who goes by the username A1candidate provided the following contribution. Following this contribution, he/she was also banned from editing the acupuncture article.

Britain’s National Health Service says that acupuncture is used in the majority of pain clinics and hospices in the UK and it is “based on scientific evidence that shows the treatment can stimulate nerves under the skin and in muscle tissue”.[2]

Cancer Research UK says that “medical research has shown that acupuncture works by stimulating nerves to release the body’s own natural chemicals.” [3]

Additionally, on 16 December, a long-time editor called LesVegas was also banned from editing the acupuncture page. The reason given? That he had repeatedly tagged the acupuncture article as violating Wikipedia’s neutral point of view policies – specifically, because it incorrectly refers to acupuncture as pseudoscience.

Directly before being banned from editing, he posted a comment to the page of Jim Wales, founder of Wikipedia, asking the following:

“. . .I can’t help but wonder if your strong and necessary response to some pseudoscience pushers has, unwittingly, emboldened a group of editors who see it as their mission to disparage all fields they deem pseudoscience. Take a look at the Acupuncture article, for instance. In the lede it says that “acupuncture is a pseudoscience”, definitively as if it came from the Mouth of God (and not merely the opinions of a couple of scientific authors.) Since there are numerous Cochrane Reviews which show acupuncture’s efficacy for various conditions, as well as WHO, NHS and NIH consensus statements about acupuncture’s efficacy for certain conditions, how can such a statement fall within our neutrality guidelines? Of course the entire scientific community hasn’t established the consensus that acupuncture is pseudoscience. States don’t have licensing boards for obvious pseudoscience, nor do scientists publish hundreds if not thousands of studies on obvious pseudoscience each year like they do with acupuncture . . . Whenever high-quality systematic reviews or meta-analyses show acupuncture in a positive light, they are rejected or deleted by these same editors who cherry-pick their own reviews and give them prominence . . . Do you believe articles like Acupuncture, which give QuackWatch more prominence than the NIH, fall within the spirit of this project? LesVegas (talk) 01:09, 16 December 2016 (UTC)”

Hours after posting this, LesVegas was indefinitely banned from editing the acupuncture article or anything remotely related to it.

Indisputably Pseudoscience? There’s No Contest

While every issue has multiple perspectives, what’s amazing is how woefully lopsided this particular debate is. The view expressed by the Wikipedia admins, which they are systematically bullying and banning Wikipedia compliant editors to defend, is one backed by un-referenced, easily disproven, error-prone opinions and fabrications. The majority of the remaining Wikipedia ‘community,’ after banning dissenters, appears to have no background in medicine or medical research. The crux of their argument relies on denying the existence of dozens of documents that demonstrate medical consensus in favour of acupuncture that clearly do exist. And this behaviour is from individuals claiming to speak on behalf of scientific rigour and rationality! It would be quite funny if it didn’t actually cause serious, systematic harm by steering people away from one of the most effective and safest treatment options ever studied. Meanwhile, as opposed to other areas of medicine, where topic experts are encouraged to participate if not relied upon for accuracy, acupuncture researchers and medical professionals who use this intervention and are versed in the literature are discouraged and banned from editing.

While Jimmy Wales and other decision-makers at Wikipedia have historically been anti-complementary medicine, the maintenance of the perspective that acupuncture is incontrovertibly pseudoscience in the face of so much evidence to the contrary comes at a steep price. It depends on censorship, denialism, and the compromising of every standard for judging scientific consensus and efficacy, not to mention escalating violations of Wikipedia’s own policies of conduct. The silly thing is that real scientists and the most rational people regularly update their theories on how things work based on new evidence. Hopefully, in the not too distant future, the acupuncture article will benefit from these rational perspectives.

]]>http://www.abetterwaytohealth.com/wikipedia-we-have-a-problem/feed/0984The Trouble with your analysis, Dr Labos. Point by point.http://www.abetterwaytohealth.com/the-trouble-with-your-analysis-dr-labos-point-by-point/
http://www.abetterwaytohealth.com/the-trouble-with-your-analysis-dr-labos-point-by-point/#commentsThu, 04 Aug 2016 12:57:59 +0000http://www.abetterwaytohealth.com/?p=957This past Sunday, the Montreal Gazette published an opinion piece by a local doctor, Christopher Labos. The main thrust was a rehash of arguments made by a small group of self-proclaimed skeptics who are intent on explaining away the evidence of acupuncture’s effectiveness, such as the Cochrane Systematic Reviews below. Below, I respond to Dr Labos, point by point. “Acupuncture ...

]]>This past Sunday, the Montreal Gazette published an opinion piece by a local doctor, Christopher Labos. The main thrust was a rehash of arguments made by a small group of self-proclaimed skeptics who are intent on explaining away the evidence of acupuncture’s effectiveness, such as the Cochrane Systematic Reviews below.

Below, I respond to Dr Labos, point by point.

“Acupuncture has been particularly popular recently and its interest was bolstered by a recent Cochrane review suggesting it might help with tension type headaches.”

“First, the data listed in the meta-analysis didn’t match the data presented in the published studies.”

. . . Errrr, is that the end of your first point? That’s fine if you’ve found a typo in the data table (out of curiosity, where was it? Do you have a page or table number?). But in order for this ‘statistical problem’ to be relevant to your argument against acupuncture, I’m curious to know, does correcting the error actually change the outcome? I’m thinking that if it did, you would have mentioned it.

“Second, the review used a fixed-effects rather than a random-effects model. This is a subtle statistical point, but it means that a less rigorous statistical approach was used.”

Huh, I’ve never heard of fixed-effects referred to as being “less rigorous” before, it’s really just a question of using the appropriate model for the particular review. My understanding is that this model is used when heterogeneity is assumed to be low. And indeed, the authors of the review write: “For the comparison versus sham we calculated pooled fixed-effect estimates, their 95% confidence intervals, the Chi-squared test for heterogeneity and the I-squared statistic. If the P value of the Chi-squared test for heterogeneity was < 0.2 and/or the I-squared > 40% we reported random-effects estimates in addition.” 1

So basically, they started with the assumption that there was low heterogeneity and then they tested this assumption. If this assumption was incorrect, they also reported Random Effects. The application of different statistical approaches is somewhat subjective and there’s no indication that their approach lacked rigour. And of course, there’s the obvious question that I’ll repeat yet again: if they used a random effects model, would that have changed the conclusion of the results? If not, then it isn’t really a problem for acupuncture, is it?

“My big problem with the paper, though, was that the reported benefit was largely driven by one trial. This 2007 study examined traditional acupuncture against “sham” acupuncture where needles were inserted in random locations.

There was no significant difference between the two groups in terms of the trial’s primary endpoint. Roughly 33 per cent and 27 per cent of patients responded, respectively. However, the study’s authors then proceeded to redefine what constituted success, and the success rates jumped to 66 per cent and 55 per cent. I become worried when endpoints change and negative studies become positive.”

Well gosh, I’m sorry if this study worried you. But in a systematic review, it’s not really as important how the study authors defined success so much as how the reviewers define success. For the primary endpoint, this study defined “a responder” as someone who had a 50% reduction in headaches. But, they would be defined as a “non-responder” even if they did have a 50% reduction in headaches if they changed their medications. Using the stricter definition that turned responder into non-responders, they had non-significant results. But, they noticed positive results for their secondary endpoints, which made them wonder why the primary endpoint was negative. So they did a re-analysis using the criteria set forth by the International Headache Society, which is a >50% reduction in headaches but doesn’t include all the additional exclusions.

But, to get to the relevant bit, how did the Cochrane Reviewers define a responder? “The main efficacy outcome measure was response (at least 50% reduction of headache frequency)”2

So it really doesn’t matter if the endpoint was primary, secondary or 98th in the study, if it was original or changed 15 times. What matters is what the reported results were for the outcome of interest of the review, which is clearly the one using the definition set out by the IHS and the ones that the reviewers extracted.

“How can the response rate be so spectacularly high?”

Well there’s a question!! Mr Occam tells us that the simplest answer is usually the correct one. The evidence suggests that the intervention is effective. At least, that’s the unbiased interpretation.

“It’s worth noting a quote from another study by the same research group. In that study, on low-back pain, the authors stated: “Effectiveness of acupuncture, either verum (true) or sham, was almost twice that of conventional therapy.

In other words, no matter what was done — whether traditional acupuncture or some guy randomly sticking needles into your back — people felt better. In that study, the response rate was 47.6 per cent for true acupuncture, 44.2 for the sham group, and 27.4 per cent for those who had nothing done to them.

The truth is, most of the benefits of acupuncture likely stem from the placebo effect.”

Ok, let’s break this down a bit. First, you’re saying that there are benefits to acupuncture. And you’ve provided good evidence that this benefit is substantial. Second, if most of the benefits are from placebo (which is true of most pharmacological interventions) then the rest of the benefits are from the acupuncture itself. I’m glad we’ve cleared that up.

But it needs to be pointed out that ‘some guy randomly sticking needles into your back’ is not a placebo control. Indeed, the sham protocol itself, sticking needles superficially in the back on either side of the spine, is not distinct from what many acupuncturists do as part of their treatment. As this is not a placebo control, lack of significant difference between the two groups at 6 months does not tell you if acupuncture is better than placebo. Furthermore, if we assume a true difference in effect size between acupuncture and sham of .2 (based on the Vickers 2012 individual patient meta-analysis using data from nearly 18,000 patients)3, the study you mention was grossly under-powered to detect this difference. One simply cannot conclude that it doesn’t matter where you stick the needles based on this study because it was too small to address this issue.

Now, both acupuncture and sham acupuncture were twice as effective as guideline-based conventional treatment. So what did this treatment involve?

“Conventional therapy included 10 sessions with personal contact with a physician or physiotherapist who administered physiotherapy, exercise, and such. Physiotherapies were supported by nonsteroidal anti- inflammatory drugs or pain medication up to the maximum daily dose during the therapy period. Rescue medication was identical to that for the acupuncture groups.”4

Ok, so explain your theory to me again. Chronic low back pain is a notoriously difficult condition to treat and one that does not tend to spontaneously get better. Compared to 10 sessions with a caring physician or physiotherapist administering physio and exercise, patients who had an intervention involving very limited communication with a practitioner sticking small needles into their back that stimulate nerve endings, release endogenous opioids and alter local tissue perfusion had twice the rate in successful outcomes, both in terms of pain reduction, function and reduction in pain medication.

So how do you propose that this treatment is able to achieve such a high placebo response? The placebo response in getting 10 treatments from a physio or doc with free-flowing caring attention while popping NSAIDs is phenomenally high. Can you elaborate on your theory? You seem to be using the ‘it’s mostly placebo’ line as some sort of magic wand to sweep away results that go contrary to your personal beliefs and opinions without applying any critical thinking or evidence to support your theory. Could you please explain how an intervention can be twice as effective as 10 treatments with a doctor, exercise and medication through the power of placebo alone? And can you provide some evidence to back it up?

“Proponents of traditional acupuncture say inserting needles along meridians redirects the Qi, a life force energy that flows from organs to the skin. Having looked inside many human bodies over my career, I can tell you that no such meridians exist.”

Huh, that’s interesting. Can I just ask, when you were looking inside of these bodies, did you ever see alpha-waves in the brain? How about a QRS complex? Or a neuronal action potential? These are all realities that are pretty important to human functioning and yet impossible to see when looking inside of a body. Are you saying, that these don’t exist?

Experimental research suggests that acupuncture’s channels are functional channels through which signals (chemical, electrical, and mechanical) preferentially flow. They tend to be close to fascial planes richer in interstitial fluid and mast cells, aiding chemotaxis, as well as fine nerve endings. It seems that a channel is not so much an object (like a bone or an eyeball) as it is where you find a movement of biochemical and bioelectrical factors that aid communication to keep the body healthy.5

There is experimental evidence that this same communication network is involved in embryological development. For example, have you ever considered how in foetal development, a bud that’s growing into an arm somehow “knows” where the upper arm ends and the forearm begins? This information isn’t in the DNA, as this contains the complete set of information for all body parts and proteins. Each part of the developing embryo “knows” where it is and what proteins to make due to an information network involving biochemicals (particularly morphogens) and bioelectric signals.6 As this bio-information network has been proven to exist and yet is largely ignored by conventional medicine (with the notable exception of oncology), some circumspection is required.

“The larger problem is that it is impossible to completely tease out the placebo effect when it comes to acupuncture. It is not like trials with medications, where the placebo group is given sugar pills.”

I couldn’t agree more and thank you for providing some actually useful commentary here. Due to the nature of randomised trial design, it is simply impossible to separate treatment and placebo effects for any non-pharmacological intervention, such as surgery, physiotherapy, talking therapy or acupuncture, which is why it’s so puzzling that you so confidently attribute acupuncture’s overwhelming success in these studies to placebo when you are fully aware that you simply cannot determine that experimentally.

“A number of placebo techniques have been tried. For example, needles can be inserted into the patient randomly or only superficially. There are also special retractable needles that pop back into the shaft of the device after piercing the skin. However, patients who’ve undergone acupuncture know what the traditional procedure is supposed to feel like, and where the needles are supposed to go. At the same time, the practitioners obviously know whether they are using real needles or inserting them differently, and their behaviour often clues in the patients as well.

Not surprisingly, this has led to the finding that much of the effect of acupuncture is guided by the acupuncturist’s style and bedside manner more than anything else.”

Yep, practitioner style and bedside manner influences much of the effect of all interventions, including pharmacological interventions 7(Vase 2015). That’s a feature of treating humans with health problems, not a feature of acupuncture.

“Some will use the “what’s the harm” argument and suggest that any benefit — even that of a placebo — is worth the effort. I disagree.

For one thing, acupuncture is not entirely risk-free. Complications like infections and punctured lungs have been reported, as Edzard Ernst details in his 2011 paper in Pain.

As well, the practice uses precious health care resources we can scant afford to waste in a time of repeated budget cuts.

Finally, the medical profession decided long ago that selling placebos to patients was unethical, no matter how convenient or profitable it might be.”

No, no, no. Please listen closely and pay attention. This really is not complicated. The question is not “What’s the harm?” The question is “what is the risk to benefit ratio and how does it compare to other available treatments for the condition in question?” As you have explained, acupuncture is much more effective than available alternatives for a number of conditions and that these effects are not entirely explained by placebo effects. These available alternatives, such as NSAIDs and opioids, are extremely dangerous and contribute to healthcare costs in a disastrous way. Acupuncture, on the other hand, is exceedingly safe.8

Based on the available research, recommending against this treatment is unethical and pretty darn silly if your aim is to simultaneously help patients get better and reduce the risk of harm you expose them to in the process.

In fact, let me ask you a question. You’ve looked at a rigorous Cochrane Systematic Review of acupuncture for tension type headaches, and other than some invalid quibbles that don’t affect the conclusion, you couldn’t find anything substantively wrong with it. This review, considered to be the pinnacle of the evidence-based medicine hierarchy, found that acupuncture was both efficacious (better than sham) and effective (better than usual care) and yet in spite of this high quality evidence, you still recommend against acupuncture for this condition. So, what do you specifically recommend for tension type headache and what research evidence do you base this on? It’s all well and good to sit there saying that acupuncture offends your firmly held beliefs in spite of the clinical evidence-base, but what do you tell your patients to do instead? And based on what?

]]>http://www.abetterwaytohealth.com/the-trouble-with-your-analysis-dr-labos-point-by-point/feed/4957Professor Ernst, a few questions about the new NICE guidelineshttp://www.abetterwaytohealth.com/professor-ernst-a-few-questions-about-the-new-nice-guidelines/
http://www.abetterwaytohealth.com/professor-ernst-a-few-questions-about-the-new-nice-guidelines/#commentsFri, 29 Apr 2016 18:02:17 +0000http://www.abetterwaytohealth.com/?p=951Dear Professor Ernst, I appreciate you’re busy, but I was wondering if you could explain a few things to me. As the only professor of complementary medicine on the planet, you have unique insight and perspective on the new updates to the NICE Guidelines for low back pain. I understand that you expressed that the removal of the recommendation for ...

I appreciate you’re busy, but I was wondering if you could explain a few things to me. As the only professor of complementary medicine on the planet, you have unique insight and perspective on the new updates to the NICE Guidelines for low back pain. I understand that you expressed that the removal of the recommendation for acupuncture is good news for patients and indeed for society! That is very exciting! Yay!

But there were a few things I didn’t understand and I was wondering if you could clarify. First, you seem to approve of the recommendations of exercise, talking therapy, and patient education, even though none of these were more effective than sham/placebo. But I thought you said that if an intervention doesn’t outperform sham, it doesn’t really work. It’s just working through placebo and non-specific effects and thus it shouldn’t be offered. So why is it good to recommend these and not recommend acupuncture?

Second, it looks like the NICE made a bit of a boo boo. Acupuncture really did outperform sham for pain relief and some other things. Does the new evidence change your opinion? Or does your opinion stand regardless of any new information?

Finally, I understand that you share the opinion that acupuncture is just a theatrical placebo and I wondered if you could put that into perspective regarding the results below from NICEs evidence review.

These results show that acupuncture was just about the most effective therapy of all the interventions reviewed by NICE for short-term pain relief. I understand that this is just one comparison, but a similar picture emerges for other measures. And even if it didn’t, ‘pain relief’ is probably a pretty important outcome measure for interventions to do with back pain.

Now, if acupuncture is ‘just a placebo’ as you say, then how does it get its placebo effects to be so much bigger than all of these other treatments (which were all recommended in the NICE guidelines even though some had no demonstrated effectiveness or efficacy), including ‘combined physical + psychological’ interventions. I mean, specifically, can you explain the mechanism? Because it seems a pretty neat trick! I mean, should we really not give patients the option of pain relief because of the remote possibility that the effects aren’t specific and offer them other, less effective treatments that have no demonstrated specific effects to speak of themselves?

And is it really more likely that acupuncture is wonderfully effective for pain relief but works only through placebo and empathy rather than working through a combination of non-specific, placebo and copious well documented specific effects? I mean, I accept that your explanation is possible, but is it really the most likely?

I’m also very interested in your thoughts about some of the other issues with the guidelines, that is, when you have time.

]]>http://www.abetterwaytohealth.com/professor-ernst-a-few-questions-about-the-new-nice-guidelines/feed/5951The NICE Low Back Pain Guidelines: A Big Misunderstandinghttp://www.abetterwaytohealth.com/the-nice-low-back-pain-guidelines-a-big-misunderstanding/
http://www.abetterwaytohealth.com/the-nice-low-back-pain-guidelines-a-big-misunderstanding/#commentsSun, 24 Apr 2016 18:04:58 +0000http://www.abetterwaytohealth.com/?p=905On 24 March, the National Institute for Health and Clinical Excellence (NICE), a UK based organisation tasked with providing evidence-based clinical guidelines for the National Health Service, released a draft of its updated guidelines on the management and treatment of low back pain with and without sciatica. The biggest news was that acupuncture, recommended in the previous version based on ...

]]>On 24 March, the National Institute for Health and Clinical Excellence (NICE), a UK based organisation tasked with providing evidence-based clinical guidelines for the National Health Service, released a draft of its updated guidelines on the management and treatment of low back pain with and without sciatica. The biggest news was that acupuncture, recommended in the previous version based on overwhelming evidence, was no longer being recommended, apparently due to poor performance compared to minimal/sham acupuncture, according to the guideline developers.

This news has been unwelcome to many, with thousands of acupuncturists, patients and GPs expressing their displeasure with the new recommendations. But having had the opportunity to familiarise myself with the recommendations laid out in a series of meaty PDFs and the research on which they are presumably based, I think it’s fair to say that this is probably all just a huge misunderstanding. Below I lay out some of the points on which the guideline development group (GDG) seem to be confused and hopefully shed some light that will lead them to a more reasonable set of conclusions.

Point of Confusion 1: They Didn’t Understand the Research Question

The GDG were asked to find out if acupuncture was clinically effective for the treatment of low back pain with or without sciatica. After assessing the published research, they found that acupuncture demonstrated “clinically important benefits in terms of improvements in quality of life . . . Benefit was also observed in pain and function ≤4 months, identified from a large body of evidence.” P494

Simply put, they found that the answer to the question “is acupuncture effective for treating low back pain?” based on a large body of research was a resounding “yes.”

And yet, they seem to have gotten confused and recommended against it. Why on earth did they do that?

They write: “The GDG first discussed the necessity of a body of evidence to show specific intervention effects, that is, over and above any contextual or placebo effects. It was therefore agreed that if placebo-controlled evidence (or sham acupuncture) is available, this should inform decision making in preference to contextual effects, but that the effect sizes compared with usual care would be important to consider if effectiveness relative to placebo, or sham, has been demonstrated.” 1

But was that what they were supposed to do?

Effectiveness vs Efficacy

It is really easy to get confused about the difference between effectiveness and efficacy. For a start, both words begin with the letter “e” and both have four syllables. They also both have to do with measuring whether or not a treatment “works.” But understanding the difference isn’t just important for impressing your mates during a pub quiz.

Essentially, when we ask “which treatment is more effective?” we’re asking the question that we ask when we have a real life clinical issue like low back pain. Of all the treatments on offer, which option is most likely to help me get better with the least risk? When we ask if a treatment outperforms a sham treatment, a choice we’re never faced with in real life, we’re asking the question: “is this treatment efficacious?” It’s a hypothetical, academic question. In a highly controlled set up that has limited application to the real world (known in research lingo as “poor external generalisability”), which performs better?

For the development of clinical guidelines that will inform treatment options for real people in the real world in real pain, any five-year old, gerbil or well-looked after ficus plant could tell you that the relevant question is that of effectiveness, not efficacy. But fortunately for the GDG, there is an even more authoritative view. Because NICE itself has actually explained what the GDG is supposed to be looking at when making clinical recommendations: “NICE prefers data from head to head RCTs to compare the effectiveness of interventions. . . . Effectiveness [is] the extent to which an intervention produces an overall benefit under usual or everyday conditions.”

Well that seems clear enough. But is there still a chance, however slight, that it’s me, and not the GDG, that has the wrong end of the effectiveness vs efficacy stick?

It doesn’t look that way. In November 2014, BAcC CEO Nick Pahl contacted NICE for clarification on this very issue. In a letter dated 17 July 2015, he received a reply from Professor Mark Baker, NICEs Director of the Centre for Clinical Practice, who is responsible for designing the methods for producing NICEs clinical guidelines. Regarding these very guidelines, Professor Baker writes:

“I can confirm that our evidence reviews for this topic are looking for evidence that:
• is not limited to RCTs
• Is not limited to placebo comparisons
• Focuses on effectiveness rather than efficacy” – Professor Mark Baker, NICE CCP

Ok, so that’s pret-ty darn clear. According to NICEs clinical guideline development director, the evidence review for the guideline on low back pain is meant to focus on “effectiveness rather than efficacy.” The GDG most definitely got the wrong end of this particular stick and has no legitimate grounds for recommending against an effective (safe, and cost-effective) treatment on the basis of presumed lack of efficacy.

I’m really glad that we’ve cleared that up.

Point of Confusion 2: Sham Acupuncture is not a placebo control and the difference between acupuncture and sham is not a measure of non-specific effects

So, confused about what they were actually supposed to be doing, first, the ‘GDG decided to ascertain if the intervention has treatment-specific effects over and above the contextual or placebo effects, and the best comparator to prove this would be a placebo or sham.’ 2 This line of reasoning sort of makes sense if you don’t think about it too hard. In research, we use sham surgery to see if surgery works and we can use sham exercise and sham therapy to evaluate the real deal. So, sham acupuncture must be a good placebo control to test efficacy, right?

There’s a small problem with this line of reasoning: it’s not evidence (or reality) based. A sham or placebo control only works if it’s biologically inert and not providing any of the same physiological effects as the treatment itself. The nature and suitability of sham acupuncture as a control for non-specific effects enjoys a robust literature and it is ubiquitously homogenous in its conclusions: sham acupuncture is not biologically inert.

In addition to successfully controlling for placebo and non-specific effects, it also controls for part of the needling effect, which is to say, part of the acupuncture treatment itself. So the difference between acupuncture and sham acupuncture is not a matter of treatment effects over and above placebo. It is a matter of the difference between a more robust, thorough, internally consistent approach to acupuncture and a less specific, less robust acupuncture treatment. It’s like comparing full-strength Aspirin to Baby Aspirin but pretending the Baby Aspirin is a sugar pill when you interpret the results, and that’s just plain silly.

In order for a control to be suitable in measuring efficacy, it has to not do any of the specific, physical things that the active treatment does. Sham acupuncture spectacularly fails at achieving this.

Not convinced? Let’s take a look at the basic science

The insertion of an acupuncture needle provokes a number of physiological changes. It activates fine nerves (groups I-IV afferents, depending on location and technique). So does ‘sham’ acupuncture, just less so. 3

The insertion of an acupuncture needle triggers tissue fibroblasts to release adenosine, an anti-inflammatory and neurotransmitter with both local and systemic effects. Adenosine is responsible for some of acupuncture’s local painkilling effects. Sham acupuncture does this too, but less so. 4

A 2009 study looked at the brains of fibromyalgia patients before and after treatment with acupuncture or sham acupuncture. It has long been understand that placebo treatments can activate our ability to produce endogenous opioids, our body’s own natural painkillers. But the study found that only true acupuncture, not sham acupuncture, caused an increase in the binding of opioid receptors in the short- and long-term. 5 In other words, both treatments increased natural pain killers but only true acupuncture improved the body’s ability to use them.

As a final example, a recent study on mice looked at changes in neuroprotective gene expression following acupuncture at a point on the arm called San Jiao 5. Compared to both handling control and control with a sham point, the study found a significant increase in gene expression for two neuroprotective proteins in the cerebellum, a part of the brain involved in coordinating muscle movement. But one of these proteins also increased at the sham point, just not as much as at the acupuncture point. Sham acupuncture had a direct physiological neuro-protective effect in the brain; true acupuncture also did but to a much greater extent. 6

Interpreting sham-controlled acupuncture trials as if they were only controlling for placebo and non-specific effects is fundamentally flawed and I’m personally unaware of any published evidence that suggests the contrary. If the GDG is aware of any, I’d be happy to read it. Sham/minimal acupuncture is a physiologically active intervention. Thus, NICE did not actually find evidence that acupuncture works solely through non-specific effects as they indicate in their draft.

But I can see why they were confused.

What does this mean for “clinical significance”?

“Ok, Mel, I hear ya, sham acupuncture is definitely not a physiologically inert placebo control. That I’m totally clear on. But didn’t the NICE committee find that acupuncture and sham acupuncture performed equally well? And doesn’t that mean that both acupuncture and sham acupuncture work better than usual care, but it doesn’t matter where you stick the needles?” I hear you ask . . .

Excellent questions. But before we answer that, we need to understand how the GDC defined ‘efficacy.’

In trials comparing drugs to sugar pills, we don’t just want a drug to do better than placebo (which would be a statistically significant difference). We want it to do better enough that we’d actually write home about it – this is known as achieving ‘clinical significance.’ A treatment achieves a clinically significant result when it outperforms placebo by at least a certain amount, known as the ‘minimal important difference’ or MID. In the case of the NICE guidelines, the minimal important difference was agreed upon by a show of hands.

Ok, so MIDs are important when comparing an active treatment to an inert control like a sugar pill, but what about when a treatment is compared to an active comparator like sham acupuncture? In this case, clinically important differences have no clinical or logical meaning. If what we want to know is whether or not acupuncture works better than pseudo-sham acupuncture, we want to know if the results are statistically significant. In other words, we want to know whether people getting acupuncture have better results than those getting sham acupuncture and whether or not these results are robust or are likely due to chance.

Acupuncture was compared to sham acupuncture for 32 outcomes. Of these, the GDC found that acupuncture outperformed sham with statistically significant results in 11 of these and sham outperformed acupuncture in 1 outcome looking at psychological distress. However, the one negative result was due to another source of confusion: a typo. In reality, acupuncture outperformed sham for 12 outcomes; sham out-performed acupuncture in none 7.

For the 21 short-term comparisons, acupuncture significantly outperformed minimal acupuncture in 8. Again, there was no evidence of equivalence between acupuncture and sham as sham never outperformed acupuncture. Acupuncture achieved NICEs arbitrary and somewhat nonsensical definition of ‘clinical significance’ for ‘all but one of the individual domain scores of SF-36 quality of life . . . Composite physical score . . . Depression as measured by HADS.’

“The GDG noted that although comparison of acupuncture with usual care demonstrated improvements in pain, function and quality of life in the short term, comparison with sham acupuncture showed no consistent clinically important effect, leading to the conclusion that the effects of acupuncture were probably the result of non-specific contextual effects.” 8 But since sham is a biologically active control, was that a reasonable, logical conclusion based on the data in front of them?

They note that acupuncture did not achieve a so-called clinically important effect over sham for pain reduction, but this is the result of yet more confusion! As Dr Mike Cummings so astutely points out, some of the numbers in their analysis do not seem to correspond to the numbers in the actual studies. When we use the real numbers. we do find that acupuncture’s superiority over minimal acupuncture is not just statistically significant but also meets NICEs definition of clinical significance. A lot of their justification for not recommending acupuncture rested on the confusion based on this error. So I’m really glad that we’ve cleared that up.

Point of Confusion 3: Errors of Omission

There were a couple of relevant results for acupuncture that the guidelines did not include without giving a reason for doing so. Perhaps they missed them? Forgot them? Didn’t like the font? It’s hard to say.

The first one has to do with something called ‘response rate.’ Most of the results look at symptom improvement, such as a reduction of pain, on a continuous scale (such as being asked to rate pain on a scale of 1 to 10). But a response rate measures the percentage of people in each group that have a certain level of improvement. In this case, NICE has defined that as 30% improvement or greater in either pain or function.

For some reason, the data from Haake 2007 was left out. This study reported the number of patients in each arm who successfully achieved a 33% improvement or better in pain reduction. Each arm had 387 patients. Verum acupuncture achieved success in 229 versus sham acupuncture’s 197. So if you were in the real acupuncture group you were significantly more likely to have successful pain reduction than if you had sham.

In looking at whether acupuncture treatment resulted in a decrease in healthcare utilisation, they also missed out some relevant findings from Brinkhaus 2006. This study found that compared to the sham acupuncture group, those in the verum acupuncture group took less than half as many pain meds. This detail invites circumspection in interpreting the lack of significant difference between the two groups in terms of pain reduction. Perhaps the difference in pain reduction wasn’t statistically significant, but unlike the real acupuncture group, the sham acupuncture group was still was still popping painkillers like pez!!9

Point of confusion 4: Acupuncture treatment leads to reduced self-efficacy, activity, exercise and an overall decline in healthy behaviour

I can see why you might want to protect patients from the slippery slope of becoming dependent on acupuncture if there’s a risk that acupuncture treatment is associated with a decline in self-management, activity and exercise. In fact, before my first acupuncture experience, I was worried that the practitioner would discourage me from looking after myself or participating in healthy activities so that I would get hooked on her effective, but non-specific treatments.

But fortunately a UK-based 2015 study showed quite the opposite! Compared to usual care, those randomised to acupuncture for chronic neck pain had a significant improvement in self-efficacy at both 6 months and 12 months. This sort of makes sense since traditional acupuncture treatment includes lifestyle advice, including diet, exercise and rest, as part of its package of care. Incidentally, the study also found that, compared to usual care, acupuncture treatment resulted in a significant and long-lasting reduction in pain. 11

Point of Confusion 5: Acupuncture must prove its efficacy, other recommended treatments not so much

It’s clear that, due to a number of misunderstandings, the GDG thought that by not recommending acupuncture, they were protecting patients from pain reduction and improved quality of life from non-specific effects, a fate they deemed worse than not getting better at all.

But what about the other treatments that NICE recommended, like exercise, psychological interventions, or a bunch of different treatments wrapped into a pretty little package? If acupuncture didn’t get the nod because of the vanishingly remote and scientifically disproved view that its effectiveness comes from a heady cocktail of empathy and placebo, what of the treatments that NICE did recommend?

Exercise therapy – Let’s use the real numbers, shall we?

The current draft recommends exercise therapy for low-back pain, so let’s see what an efficacious treatment really looks like, according to NICE.

There were two placebo/sham controlled comparisons for exercise: pain reduction in the short-term and pain reduction in the long-term. In the short-term, exercise had a clinically meaningful benefit over sham exercise but not in the long-term. I’m not sure this classifies as the ‘consistent clinically important effect’ compared to sham that they hold acupuncture to but here we find another problem. And yes, it is another data error.

The data used to assess exercise vs sham for pain reduction in the short-term seems to be the figment of some NICE committee member’s imagination as it bares too little resemblance to the actual numbers to constitute a simple typo. Using the real numbers from the study, we find that exercise therapy has no clinically important benefit over sham in either the short- or long-term.

So it looks like exercise therapy now fails the ‘acupuncture efficacy hurdle.’ Now that’s confusing, does that mean that the GDG needs to update its recommendation of exercise?

Psychological interventions – predefined critical outcomes? Or make it up as we go along?

The GDG recommends psychological therapies as part of a multi-modal treatment package. Surely, unlike exercise, this treatment had some of that all important consistent demonstration of efficacy?

For cognitive behavioural approaches, the GDG writes: “No clinical benefit was observed for people with low back pain with / without sciatica when cognitive behavioural approaches was compared to sham or usual care or waiting list controls for the majority of reported outcomes.” 12

<<Hold on a sec, I just snarfed my merlot>>

The GDG has indicated that a treatment cannot be recommended if the evidence does not strongly support a specific treatment effect. And now they’re saying here, not only did this approach not outperform sham, but it didn’t outperform usual care or waitlist? They’re recommending it even though it’s not effective or efficacious?

And wait a sec, I remember reading about waitlist control in the acupuncture section. “It was noted that 4 of the included studies had a ‘waiting list’ group as their usual care comparison. It was considered that this may over-estimate the effects of treatment as people may become disheartened in the comparison group whilst waiting to start active treatment . . It is noted this applies to all reviews with usual care comparators and has been taken into account equally across interventions reviewed in this guideline.” 13 Noted.

Ok, I know the GDG was confused, but how did they justify recommending a treatment that according to the evidence they looked at, didn’t work at all?

They start off by saying that “The GDG agreed that health related quality of life, pain severity, function and psychological distress were the outcomes that were critical for decision making” for psychological interventions.14 And then if we skip forward a few paragraphs, including the ones where they say that the treatment wasn’t effective for any of their outcomes we find the following: “The primary aim of a cognitive behavioural approach is not to directly improve pain and function, but reduce the fear of pain, thus increasing people’s confidence in undertaking physical rehabilitation and therefore the GDG considered it unsurprising that meaningful effects were not seen in these outcomes.” 15 They then went on to recommend it.

So to paraphrase, 1) the GDG had a predetermined set of agreed upon criteria for recommending a treatment. 2) It found that the treatment in question did not meet these criteria. 3) It went on to recommend it anyways. That is really confusing.

It’s all well and good to say that cognitive approaches work by reducing fear of pain, but if that’s the case, then shouldn’t that have been one of the critical outcomes for decision making? And sorry, did I mention that cognitive therapy didn’t even outperform waitlist control in reducing psychological distress?!!!!!

Surely you agree that if cognitive therapy is doing anything at all for low back pain sufferers, it should at least be able to reduce psychological distress better than giving people the ‘disheartening’ and psychologically distressing situation of waiting for treatment without actually providing one.

Point of Confusion 6: It’s ok to recommend a placebo, as long as it’s not recommended on its own

Brown paper Backages tied up with string

“But Mel,” you quickly point out. “Sure, there’s no rational way that they could recommend against acupuncture given how well it performed and yet recommend a treatment like cognitive therapy that couldn’t even outperform a psychologically distressing control. But they aren’t recommending it on it’s own, they’re recommending it as part of a package of care.”

The NICE Guidelines evaluated a heterogenous collection of combination therapies called “Multidisciplinary biopsychosocial rehabilitation programmes,” known as MBR to its mates. The section on MBR starts out with a very heartfelt description of the plight of the population with whose care the committee has been entrusted.

“Non-specific low back pain, with or without sciatica is a complex, poorly understood, multi-factorial phenomenon which impacts on people’s ability to undertake normal activities of daily living, social function and affects their mood and confidence. People are often given broad descriptions for their symptoms, rather than a definitive diagnosis. This makes it difficult to define a clear treatment plan, causing further stress.”16

Ok, according to the GDG psychological interventions aren’t meant to work on their own, so how does it work when combined with a physical intervention? According to NICEs evidence summary, a 2-element MBR programme consisting of physical and psychological elements found no clinical difference for pain or psychological distress outcomes compared to wait-list control (yep, that’s the control that according to NICE actually over-estimates the effectiveness of the treatment?).

Recommending treatments that don’t outperform sham as part of a package seems to be a bit of a theme of the guidelines. We see this again with recommendations around paracetamol and opioids. Studies comparing each of these on their own were shown to be no more effective than a sugar pill for pain relief, demonstrating that they work via non-specific effects. While the guidelines recommend against each of these on their own, they do recommend them in combination.

But wait a sec. While the performance of opioid + paracetamol vs placebo managed to eek out one clinically meaningful result for change in pain severity (but not for perceptible or meaningful pain relief, quality of life or function, all considered to be ‘critical outcomes for decision making’) since neither of these seem to help on their own, isn’t it most likely that the little they work as a combo is through placebo effects? I mean, there were no studies comparing opioid + paracetamol vs opioid + placebo or vice versa.

Indeed the only clinically impressive results for the painkiller duo were in adverse effects with a relative risk of 3.48, so patients are more than three times as likely to be harmed or injured by the treatment than placebo and yet the odds having meaningful pain relief over sugar pill are teeny. In research lingo, this treatment would be described as having a flippin’ awful benefit to risk ratio.

So I guess when the GDG said that recommending treatments that work via non-specific effects was to be avoided, even if they’re effective, the main caveat is that you can recommend two un-efficacious treatments together?

At this point, you might be asking yourself “what in the name of Britany Spears’ left tit is going on here? Who the heck are these people?”

Yes, who is the GDG?

Point of Confusion 7: Conflict of Interest Policy? What Conflict of Interest Policy? (It must have gone into Spam)

Declare and Participate

Due to accusations that NICE has become the UK based marketing and distribution arm of the pharmaceutical industry, policies surrounding conflict of interest have become very stringent in order to ensure that recommendations are based on the best interest of patients, not the personal gain of guideline committee members.

“1. NICE is expected to achieve and maintain high standards of probity in the way it conducts its business. These standards include impartiality, objectivity and integrity, and the effective stewardship of public funds. Managing potential conflicts of interest is an important part of this process.

2. The effective management of conflicts of interests is an essential element in the development of the guidance and advice that NICE publishes. Without it, professionals and the public will lose confidence in our work.

3. This policy provides guidance on what interests need to be declared, who needs to declare them and when, and what action should be taken to avoid conflicts of interest influencing the conduct of NICE’s business. Everyone referred to in this policy should ensure that they and those for whom they have responsibility understand their obligations to disclose all relevant interests.”

Makes sense. So what is their specific advice?

First, they address the role of conflicts of interest with committee chairs. “The Chairs of advisory committees are in a special position in relation to the work of their committee and so may not have any specific financial or non-financial personal, non-personal or family interests.”17

So who is the chair of this committee?

His is one Stephen Ward and in Appendix B of the guidelines, he indicates no fewer than six conflicts of interest, including a “personal pecuniary interest.” Until March of this year, he was the director of a private pain management service called Back@Work Ltd.

Ok, now I’m the one who’s confused. How can this Stephen Ward guy be the chair of the GDG committee when he has conflicts all over the place and committee chairs aren’t allowed to have conflicts of interest?

But then it goes from confusing to chaotic when we note that it’s the role of the unbiased, unconflicted and impartial chair to enforce the CoI policy for the rest of the members, which doesn’t seem to have happened. For example, all of the group members receiving payments from the pharmaceutical industry were asked to leave the room when discussing pharmaceutical treatments. But explain to me how that financial conflict of interest does not extend to voting on a treatment like acupuncture, that reduces patients’ intake of meds by over 50%? When the The Director of Back@Work Ltd asked the group to provide a show of hands to decide whether or not to recommend acupuncture, did the Pfizer guys really have no personal vested interest in the outcome?

Misunderstandings: A Summary

Taking all of the above into consideration, I’d like to conclude with a short video by Dr Ian Berstein where he summarises the GDGs misunderstandings and confusion around how they are meant to make clinical recommendations and what the data actually showed. Dr Berstein is not only a member of the guidelines development group but shares the honour of the most declared personal pecuniary conflicts of interest (ten in total). Apparently unaware that the conflict of interest policy precludes him from discussion and recommendations, he indicates that he chose to “Declare and Participate.” (Appendices A-G, pp18-21)

Let’s see what he has to say:

Regarding acupuncture, he explains:

“The evidence showed that there is no clinically important difference between acupuncture and sham acupuncture for its effects on pain. The guidelines development group thought that acupuncture was unlikely to have a specific biological treatment effect but was acting through contextual mechanisms, such as seeing a caring empathic healthcare professional or the laying on of hands.”

(Sounds like the acupuncturists need to teach the therapists how to be more caring and empathic!! Hoho)

“The guidelines development group considered that other treatments reviewed in this guideline had specific and clinically important treatment effects beyond contextual effects and that these should be prioritised for the use of healthcare resources.”

Gosh, that does sound great but I simply could not find NICEs evidence of ‘clinically important treatment effects beyond contextual effects’ for a bunch of the treatments they recommended.

Paracetamol – effective above placebo or sham? No. Recommended? Yes, recommended in some scenarios along with opioid, but no specific efficacy demonstrated.

Opioids – effective above placebo or sham? No. Recommended? Yes, recommended along with paracetamol, but no specific efficacy was demonstrated.

Hopefully this post has cleared up some of the confusion around the guideline updates and the GDG will figure out how to update their recommendations to be more inline with (accurate) data, more consistent throughout and more in line with the best interests of patients with low back pain and the National Health Service.

]]>http://www.abetterwaytohealth.com/the-nice-low-back-pain-guidelines-a-big-misunderstanding/feed/6905The UK’s Top Migraine Charity is about to reveal an effective, drug-free treatment for Migraine . . .http://www.abetterwaytohealth.com/the-uks-top-migraine-charity-is-about-to-reveal-a-safe-effective-drug-free-treatment-for-migraine/
http://www.abetterwaytohealth.com/the-uks-top-migraine-charity-is-about-to-reveal-a-safe-effective-drug-free-treatment-for-migraine/#commentsMon, 24 Aug 2015 09:13:28 +0000http://www.abetterwaytohealth.com/?p=889Did you know that there are 190,000 migraine attacks everyday in the UK? Or that an estimated 25 million days are lost from work or school every year because of migraine? How about that preventative treatments for migraines include antidepressants, antihistamines, anticonvulsants and, for the 5% of migraineurs who are eligible, Botox injections? You can find all of this out ...

]]>Did you know that there are 190,000 migraine attacks everyday in the UK? Or that an estimated 25 million days are lost from work or school every year because of migraine? 1 How about that preventative treatments for migraines include antidepressants, antihistamines, anticonvulsants and, for the 5% of migraineurs who are eligible, Botox injections? You can find all of this out and more from the Migraine Trust, the ‘health and medical research charity for migraine’ in the UK.

What you won’t find out from their website or any of their handy Factsheets is that NICE recommends a safe, effective and affordable treatment for anyone with chronic migraines who has either tried topiramate and propranolol with no joy or for whom these meds are inappropriate. This treatment was found to be just as effective with fewer side effects than standard medication according to the most recent Cochrane Systematic Review2, considered the highest level of evidence available. It has less than a third the rate of side effects as Botox 34 at about half the cost.5

What’s more, NICE have made one of their top priorities the management and prevention of medication overuse headache – the unfortunate scenario where headache meds actually cause headaches. But since this treatment is not only just as effective as medication but is completely drug free, it can play a key role in the success of the NHS and Migraine Trust strategies to achieve the reduction of this debilitating drug-induced headache condition.

The treatment I’m talking about is acupuncture. And the Migraine Trust are excited to finally share this treatment option, available on the NHS as enshrined in the constitution, to all migraine sufferers and carers alike.

Acupuncture is safer and less expensive than botox for the prevention of migraines

Why did they stay hushed for so long?

So why is there absolutely no mention of acupuncture as a treatment for migraine on the Migraine Trust website today?

It’s hard to say. NICE have only officially recommended acupuncture for the prevention of migraine for three years – in fact, it came out in the same set of guidelines as the ones that recommend Botox for a smaller subset of patients. While the Trust have provided information about Botox in their general section on treatments as well as having published an additional Botox Factsheet, they haven’t gotten around to doing the same to inform patients and healthcare providers about acupuncture, a treatment option that’s relevant to more people, costs less and has fewer side-effects.

The cynics amongst you may wonder if money has anything to do with it. The Migraine Trust aren’t shy about sharing that they are primarily funded by pharmaceutical companies including Allergan, the makers of Botox. These contributions are likely motivated by something other than altruism; I’m sure Allergan expects to see an increase in UK sales of botox for its generosity.

But not all of their donations come from pharma and it’s these little donations from regular people that add up that allow the Migraine Trust to educate the public about treatments other than ones sold by their pharmaceutical donors.

Share your gratitude

The Migraine Trust works hard to be the Migraine Charity for the UK, educating patients and healthcare providers about all of their evidence-based treatment options. If you are elated that the Migraine Trust will begin informing people about acupuncture – a safe, effective, cost-effective treatment for migraine prevention, recommended by NICE, available on the NHS, and a key tool for preventing medication overuse headaches, let them know!!